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

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 03/17/2020

Event Type  Injury  

Event Description

It was reported that during treatment the allevyn has not helped at all and seems like the ulcer is worse.It¿s not incontinence proof and starts to come off if it get wet and they have had to change it several times.The dressing was incorrectly used by the customer.

• 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
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: sarah freestone ; 101 hessle road; hull HU3 2-BN ; UK HU3 2BN ; 0447940038
• MDR Report Key: 9918828
• MDR Text Key: 186234402
• Report Number: 8043484-2020-00252
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2021
• 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): Required Intervention