MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN LIFE HEEL (GLOBAL) PACK OF 5; DRESSING,WOUND,OCCLUSIVE

Model Number	66021304
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the silicon adhesion is coming off onto the plastic backing.The product has not been submitted to a customer or used on a patient.
Additional Manufacturer Narrative
H3, h6: we have now concluded our investigation for the complaint received.The device used in treatment has not been returned for evaluation.The photo provided confirms a relationship between the device and the reported event.Silicone remained on the carrier paper reducing adhesion.Potential factors that can contribute to the reported event include the wound contact layer raw material quality issue.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.The complaint history file contains further instances of the reported event, currently being monitored, with actions being taken to reduce further instances.However, this investigation is now complete with no further action deemed necessary at this stage.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.We will continue to monitor for any adverse trends relating to this product range.
Additional Manufacturer Narrative
The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.This event may result in a loss of the moisture and bacterial barrier and may cause minor or temporary injury (e.G., delayed wound healing, maceration) requiring no or minor medical intervention.The event may require use of a backup device to continue therapy.This event did not lead to a death or serious injury, nor would it be likely to cause or contribute to a death or serious injury if it were to recur.This event is considered not reportable pursuant to 21 cfr 803.

• Brand Name: ALLEVYN LIFE HEEL (GLOBAL) PACK OF 5
• Common Device Name: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 10987541
• Report Number: 8043484-2020-04162
• Device Sequence Number: 16940542
• Product Code: NAD
• UDI-Device Identifier: 05000223482503
• UDI-Public: 05000223482503
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 66021304
• Device Catalogue Number: 66801304
• Device Lot Number: 202032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 11/13/2020
• Supplement Date Received by Manufacturer: 01/06/2021; 01/06/2021
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 01/08/2021; 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown