MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN GB MULTISITE CTN 10; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number 66800959

Device Problem Material Integrity Problem (2978)

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

Event Date 03/24/2021

Event Type  malfunction  

Event Description

It was reported that, customer complained the silicon beads of the allevyn gentle border device were sticking to the patients skin and also the backing when they peeled it apart.It is unknown when did the event happened, how was the procedure finished and if there was a delay.No other complications were reported.

Manufacturer Narrative

H3, h6: we have now completed our investigation into the reported complaint.The device used in treatment was not returned for evaluation, all provided information has been reviewed and we have not been able to establish a relationship between the device and the reported event or determine a root cause.It was reported silicone offsetting.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 GB MULTISITE CTN 10
• 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: 11683377
• MDR Text Key: 245995180
• Report Number: 8043484-2021-00859
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• PMA/PMN Number: K112127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2023
• Device Catalogue Number: 66800959
• Device Lot Number: 202049
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1