MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE BORDER 17.5X17.5CM CTN 10; DRESSING,WOUND,OCCLUSIVE

Catalog Number 66800273

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/09/2020

Event Type  malfunction  

Event Description

It was reported that during treatment the exudate was leaking from the dressing.This incident did not caused an adverse event.

Manufacturer Narrative

H10.H3, h6: we have now concluded our investigation for the complaint received.A review of the associated batch manufacturing records did not identify any issue at the point of manufacture which may have caused or contributed to the issue highlighted by the complainant.In addition, it can be confirmed that all finished product specification testing was satisfied at the point of release.A complaints history review was carried out using the lot and part numbers provided, there have been no further complaints reported with this failure mode in the past three years.The device was used for treatment.It was reported that exudate was leaking from the dressing.This issue could not be confirmed from the images provided.No samples were returned for evaluation.A clinical assessment was made.It was concluded: ¿the photos provided have been reviewed and assessed.The treatment therapy delivered including the topical cream and barrier spray reportedly resolved the exudate that was leaking from dressing.Given that the remedies for treatment on the wound area resolved the issues no further clinical assessment is warranted at this time.¿ during the early stages of treatment the dressing should be frequently inspected.As stated in the ifu for this product, dressings can be left in place for up to seven days.However, dressing changes are dependent on the condition of the wound.If exudate is visible and close to the edge of the dressing pad then a dressing change may be required.We have not been able to confirm a relationship between the event and the device or identify a root cause.No further actions by smith and nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.

• Brand Name: ALLEVYN GENTLE BORDER 17.5X17.5CM CTN 10
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 9969902
• MDR Text Key: 190429061
• Report Number: 8043484-2020-00291
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66800273
• Device Lot Number: 1921
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1