URGENT FIELD SAFETY NOTICE FLEXMEDICS PATIENT PACKS - BFARM
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FlexMedics, Inc.
Rev 1: September 2018
FSN Ref:1833132-01/24/2021-001-R FSCA Ref: 1833132-01/12/2021-001-R
Date:24:JAN:2021
Urgent Field Safety Notice
FlexMedics Patient Packs
TO WHOM IT MAY CONCERN (Place Holder for Customer Name)
Contact details of local representative (name, e-mail, telephone, address etc.)*
0FlexMedics, Inc.
Rev 1: September 2018
FSN Ref:1833132-01/24/2021-001-R FSCA Ref: 1833132-01/12/2021-001-R
Urgent Field Safety Notice (FSN)
FlexMedics Patient Packs
Risk addressed by FSN
1. Information on Affected Devices*
1 1. Device Type(s)*
.
Non-sterile elastic, orthodontic bands. Orthodontic elastics, also referred to as rubber
bands, are small stretchy loops of rubber that help move teeth into proper alignment
during orthodontic treatment.
1 2. Commercial name(s)
. FlexMedics Patient Packs
1 3. Unique Device Identifier(s) (UDI-DI)
. N/A
1 4. Primary clinical purpose of device(s)*
. Their purpose is to create additional force for tooth movement in any of the three
dimensions that is more difficult using braces alone
1 5. Device Model/Catalogue/part number(s)*
. AMD18, AMD36, AMD56, AMH14, AMH18, AMH36, AML36, AML56, LFH14, LFH36, LFM14,
LFM36
1 6. Software version
. N/A
1 7. Affected serial or lot number range
. 802028, 803093, 811672, 811673, 813659, 813660, 813664, 813666, 813669, 822714, 822716,
822724, 827154, 827161, 827172, 827173, 830878, 832605, 835151, 835158
1 8. Associated devices
. N/A
2 Reason for Field Safety Corrective Action (FSCA)*
2 1. Description of the product problem*
. While both released product and labelling are accurate, a change was made that resulted in the
color scheme of the FlexMedics Patient Packs product to be updated which was not intended and
could result in consumer confusion and/or patient discomfort. The color scheme for FlexMedics
Patient Packs elastic bands which might be used to differentiate sizes of product by different
colors was inadvertently changed. This recall does not affect any other batches/lots/versions of
FlexMedics Patient Packs or any other FlexMedics products. This version has been
manufactured since 9-OCT-2020.
2 2. Hazard giving rise to the FSCA*
. FlexMedics does not expect device failures; instead, there is an opportunity for misuse of the
device if the label is not read. If the band is too small and still applied, the band could break. If
the band is too small, the treatment may be more aggressive. It is important to note that elastic
band force decreases quickly over time. Both circumstances could result in temporary patient
discomfort.
2 3. Probability of problem arising
. The probability of a problem arising is “Not likely that use will cause any adverse events”
2 4. Predicted risk to patient/users
. The predicted risk to patients/users is minimal.
5. Further information to help characterise the problem
1Rev 1: September 2018
FSN Ref:1833132-01/24/2021-001-R FSCA Ref: 1833132-01/12/2021-001-R
2 Use of incorrect size or force value of elastic band is not likely to lead to Death,
. Permanent Impairment or injury or impairment which might require substantial
professional intervention/treatment.
2 6. Background on Issue
. FlexMedics became aware of the issue through 3 complaints (21-01-005, 20-12-057, and 20-12-
038). The complaints came from three different distributors in December of 2020. The complaints
described the incorrect color and addition of a new letter on the patient pack. No injuries or death
have been reported. All the label information written on the patient pack is correct, including part
number, elastic band size and force value. However, the color of the written text is inconsistent
with what we have manufactured in the past. The letter is also not appropriately associated to force
values, but instead also refers to band size.
2 7. Other information relevant to FSCA
. N/A
3. Type of Action to mitigate the risk*
3. 1. Action To Be Taken by the User*
☐Identify Device☐Quarantine Device ☐ Return Device Destroy Device
☐On-site device modification/inspection
☐Follow patient management recommendations
☐Take note of amendment/reinforcement of Instructions For Use (IFU)
☐ Other ☐ None
3. 2. By when should the
action be completed? As soon as possible, within the next 30 days.
3. 3. Particular considerations for:Choose an item.
Is follow-up of patients or review of patients’previous results recommended?
Patient follow-up is not recommended by the manufacturer. However, while both released
product and labelling are accurate, the change was made that resulted in the color scheme
of the FlexMedics Patient Packs product to be updated which was not intended and could
result in consumer confusion and/or patient discomfort. Doctors should assess whether the
minimal risk to patients could have been realized by applying the incorrect product.
3. 4. Is customer Reply Required? * No
(If yes, form attached specifying deadline for return)
3. 5. Action Being Taken by the Manufacturer
☐Product Removal ☐On-site device modification/inspection
☐Software upgrade☐ IFU or labelling change
Other ☐ None
FlexMedics top management intends to replace product with material representative of
customer expected color scheme as of 19-JAN-2021.
2Rev 1: September 2018
FSN Ref:1833132-01/24/2021-001-R FSCA Ref: 1833132-01/12/2021-001-R
3 6. By when should the As requested by customers
action be completed?
3. 7. Is the FSN required to be communicated to the patient No
/lay user?
3 8. If yes, has manufacturer provided additional information suitable for the patient/lay
user in a patient/lay or non-professional user information letter/sheet?
Choose an item.Choose an item.
3Rev 1: September 2018
FSN Ref:1833132-01/24/2021-001-R FSCA Ref: 1833132-01/12/2021-001-R
4. General Information*
4. 1. FSN Type* New
4. 2. For updated FSN, reference Provide reference and date of previous FSN if
number and date of previous relevant
FSN
4. 3. For Updated FSN, key new information as follows:
Summarise any key difference in devices affected and/or action to be taken.
4. 4. Further advice or information No
already expected in follow-up
FSN?*
5. If follow-up FSN expected, what is the further advice expected to relate to:
4
Eg patient management, device modifications etc
6. Anticipated timescale for follow- For provision of updated advice.
4 up FSN
4. 7. Manufacturer information
(For contact details of local representative refer to page 1 of this FSN)
a. Company Name FlexMedics, Inc
b. Address 2165 Earlywood Drive, Franklin, IN 46131, USA
c. Website address ghorthodontics.com
4. 8. The Competent (Regulatory) Authority of your country has been informed about this
communication to customers.*
4. 9. List of attachments/appendices: N/A
4. 10. Name/Signature
Transmission of this Field Safety Notice
This notice needs to be passed on all those who need to be aware within your organisation or to
any organisation where the potentially affected devices have been transferred. (As appropriate)
Please transfer this notice to other organisations on which this action has an impact. (As
appropriate)
Please maintain awareness on this notice and resulting action for an appropriate period to ensure
effectiveness of the corrective action.
Please report all device-related incidents to the manufacturer, distributor or local representative,
and the national Competent Authority if appropriate, as this provides important feedback..*
Note: Fields indicated by * are considered necessary for all FSNs. Others are optional.
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