MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE BORDER 3IN X 3IN; DRESSING,WOUND,OCCLUSIVE

Catalog Number 66800276

Device Problem Insufficient Information (3190)

Patient Problem Skin Irritation (2076)

Event Date 09/01/2019

Event Type  Injury  

Event Description

It was reported that the dressings were found to be sticky and tear off all the freshly healed skin and this worsened wounds and causes suffering.The bandages were used for at least 1 day, not more than 3 days.The wounds are now being left open or being covered with non-stick pads.

• Brand Name: ALLEVYN GENTLE BORDER 3IN X 3IN
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull ; UK
• 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: 9313705
• MDR Text Key: 166127332
• Report Number: 8043484-2019-00806
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 66800276
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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