MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. UNKNOWN ALLEVYN GENTLE BORDER; DRESSING,WOUND,OCCLUSIVE

Device Problem Mechanical Problem (1384)

Patient Problem Injury (2348)

Event Date 04/05/2019

Event Type  Injury  

Event Description

It was reported that in a heel post a pressure injury.Competitor dressing applied - initially was an eschar insitu.(b)(6) did a small debridement and removed the eschar.Then applied allevyn gentle border.(b)(6) when did dressing change noticed that exudate had pooled underneath the allevyn gentle border and resulted in maceration.White saturated wound edges - was using aquacel ag underneath the allevyn gentle border at time.Stated that the allevyn gentle border does not absorb exudate properly.

Manufacturer Narrative

The related product was not returned for evaluation, please find below the results of our investigation: we have now concluded our investigation into this complaint.No dhr/batch record review possible as no product code has been made available and no sample was received for evaluation.A review of the complaint history for this defect shows a very low level of complaints for this issue based on volumes manufactured.The information provided is insufficient to determine whether the patient¿s symptoms, signs or outcome are due to a pre-existing or concurrent medical or surgical condition or procedure, or to an adverse reaction to or experience with the device, one or more of its components, or its intended therapeutic action.A thorough medical assessment cannot be rendered at this time.The investigation did not find product defect or manufacturing process issue.The complaint sample and product code were not available at this time.Once the sample received, an assessment may take place to make further investigation.Based on the available information, the cause of the complaint is inconclusive so no action can be taken at present.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: UNKNOWN ALLEVYN GENTLE BORDER
• 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: 8566218
• MDR Text Key: 143597626
• Report Number: 8043484-2019-00301
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• 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: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other