MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN LIFE SACRUM (SMALL) PACK OF 10; DRESSING,WOUND,OCCLUSIVE

Model Number	66021306
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	11/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, silicone is ripping off in large portions from the back of allevyn life sacrum (small) pack of 10 dressings.The silicone is getting all over the patients, causing shorter wear times, and inhibiting the clinician from peeking under prevention dressings due to the fact that the silicone is just coming off and then it is impossible for the dressing to re stick.Incident occurred before the procedure; therefore, there was no patient involvement.
Additional Manufacturer Narrative
We have now concluded our investigation for the complaint received.The manufacturing records show no evidence that the product did not meet the specification at the time of manufacture, the reported file is held by the quality release team.The device used in treatment has not been returned for evaluation, with no additional information provided.We have not been able to establish a relationship between the device and the reported event or determine a root cause on this occasion.Silicone came off reducing adhesion.Potential factors include raw material issues or storage environment issues.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.We will continue to monitor for any adverse trends relating to this product range.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: ALLEVYN LIFE SACRUM (SMALL) PACK OF 10
• Common Device Name: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 11016646
• Report Number: 8043484-2020-04257
• Device Sequence Number: 19049867
• Product Code: NAD
• UDI-Device Identifier: 05000223481421
• UDI-Public: 05000223481421
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2021

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: 66021306
• Device Catalogue Number: 66801306
• Device Lot Number: 202020
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 01/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1