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

Model Number	66801307
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	05/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, it was noticed that the silicone is detached and remains on the protective plastic film.As a result, the bandage does not stick anymore.No case involved; therefore, there was no patient involvement.
Additional Manufacturer Narrative
H3, h6: the devices, intended to be used in treatment, have been received for evaluation.A visual inspection confirmed silicone remained on the carrier.The functional evaluation confirmed that the dressing had reduced bonding capabilities, establishing a relationship between the device and the reported event.The root cause was identified as a raw material issue.A review of the associated batch manufacturing records confirmed that the device met manufacturing specifications at the point of release.A complaint history review found further instances of the reported event.This investigation is now complete with further actions being taken relating to the failure reported.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 (LARGE) PACK OF 10
• Common Device Name: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 11918468
• Report Number: 8043484-2021-01319
• Device Sequence Number: 3179636
• Product Code: NAD
• UDI-Device Identifier: 05000223481452
• UDI-Public: 05000223481452
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2021

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 Expiration Date: 06/01/2023
• Device Model Number: 66801307
• Device Catalogue Number: 66801307
• Device Lot Number: 202027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2021
• Initial Date Received by Manufacturer: 05/21/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 07/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1