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	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that dressing back is sticking to patients when being removed, possibly tearing the skin of the patient.Another dressing was applied.Patient injuries were not reported.It is not confirmed that the 352 dressings reported failed, query has been sent and if further information is received this case will be updated.
Additional Manufacturer Narrative
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 event reported or determine a root cause on this occasion.The manufacturing records show no evidence that the product did not meet the specification at the time of manufacture.A review of possible causes determined that, as with all adhesive products, some irritation may be caused, particularly on those with sensitive or fragile skin.The complaint history file contains further instances of the reported event, this investigation is now complete with no further action deemed necessary at this stage.Smith and nephew will continue to monitor for any adverse trends relating to this product range.

• 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: 11304677
• Report Number: 8043484-2021-00287
• Device Sequence Number: 13635415
• Product Code: NAD
• UDI-Device Identifier: 05000223481452
• UDI-Public: 05000223481452
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2021

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: 66801307
• Device Catalogue Number: 66801307
• Device Lot Number: 202020
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 02/09/2021
• Supplement Report FDA Received Date: 03/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1