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	Material Integrity Problem (2978)
Health Effect - Clinical Code	Skin Tears (2516)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, the allevyn life sacrum is "shedding" silicone onto the patient upon removal and it's difficult to remove from the skin.It's also shedding as the backing is removed before application.It is unknown how the procedure was finished or if there was any delay.
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 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.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 east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 11057262
• Report Number: 8043484-2020-04350
• Device Sequence Number: 3013128
• Product Code: NAD
• UDI-Device Identifier: 05000223481421
• UDI-Public: 05000223481421
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2021

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
• Initial Date Received by Manufacturer: 12/02/2020
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 03/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1