MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN LIFE M 12.9X12.9 CTN10; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number 66801068

Device Problem Nonstandard Device (1420)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/07/2021

Event Type  malfunction  

Event Description

It was reported that, during dressing change, silicone is coming away from the dressing onto the liner while removing the liner for application and also silicone is staying on the skin/wound while removing the dressing to replace with a new dressing.It is unknown when did the event happened how was the procedure finished and if there was a delay.No other complications where reported.

Manufacturer Narrative

We have now completed our investigation into the reported complaint.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.It was reported that silicone is coming away from the dressing.Factors that can contribute to the reported event include, raw material issues or storage environment issues.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 events.An ongoing internal action is being carried out into the reported failure mode to reduce further instances of the reported event, therefore no further actions are deemed necessary into this specific complaint.Smith and nephew will continue to monitor for any adverse trends relating to this product range.

• Brand Name: ALLEVYN LIFE M 12.9X12.9 CTN10
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 11429785
• MDR Text Key: 238333608
• Report Number: 8043484-2021-00504
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 05000223478018
• UDI-Public: 05000223478018
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2023
• Device Model Number: 66801068
• Device Catalogue Number: 66801068
• Device Lot Number: 202016
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1