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

Catalog Number 66800276

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 01/06/2020

Event Type  Injury  

Event Description

It was reported that when the individual sealed package was opened it was found that it was full of glue.The glue attached to the wound causing the patient to had to resort to antibiotic foot soaks and the use of other nonadherent bandages.The wound is currently closed after 6 weeks of antibiotic soaks.

• 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: 9650338
• MDR Text Key: 177180509
• Report Number: 8043484-2020-00078
• 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: consumer
• Type of Report: Initial
• Report Date: 01/30/2020

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: Lay User/Patient
• Device Catalogue Number: 66800276
• Device Lot Number: 201924
• Initial Date Manufacturer Received: 01/27/2020
• Initial Date FDA Received: 01/30/2020
• 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): Other
• Patient Age: 87 YR
• Patient Weight: 86