MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE BORDER 7.5X7.5CM INT; DRESSING,WOUND,OCCLUSIVE

Catalog Number 66800269

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Injury (2348)

Event Date 01/23/2018

Event Type  Injury  

Event Description

It was reported that a nurse observed exudate leaking from the dressing but the dressing had not absorbed any exudate.She noted maceration around the periwound from the exudate.Used on a non healing cancerous wound and another on a sinus wound.

Manufacturer Narrative

Device was not evaluated due to no sample was returned for investigation.Investigation summary: our investigation into this complaint has now concluded.As of today, no additional information requested or sample for this complaint has become available.Without further information we cannot progress our investigation or confirm the details supplied in this complaint.An investigation into the manufacturing paperwork associated with this product code and lot has been carried out.This review detailed that manufacture of the product had occurred in accordance with defined procedures and specifications.No record of any problems occurring during manufacture of the product have been made which may be related to this complaint.Due to the nature of the reported issue this has been passed to one of our medical specialists who has made the following comments.The most recent customer response states, there was "nil maceration observed", "only one wound" and "this is a chronic, ongoing wound with nil changes." based on the provided information, no further clinical assessment is warranted.In the absence of additional information, our investigation remains inconclusive.At this time an exact root cause cannot be determined.If additional information becomes available in the future, this case will be reopened smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.We will continue to monitor for any adverse trends relating to this product range.

• Brand Name: ALLEVYN GENTLE BORDER 7.5X7.5CM INT
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 8N; UK HU3 28N
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 8N; UK HU3 28N
• Manufacturer Contact: markus poettker ; schachenallee 29; aarau 5001 ; SZ 5001
• MDR Report Key: 7355950
• MDR Text Key: 102990908
• Report Number: 8043484-2018-00058
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 66800269
• Device Lot Number: 201707
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2018
• Initial Date FDA Received: 03/20/2018
• Supplement Dates Manufacturer Received: 02/20/2018
• Supplement Dates FDA Received: 05/02/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR
• Patient Weight: 76