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

Catalog Number UNKNOWN

Device Problems Fluid/Blood Leak (1250); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that during a study which was comparing 3 different types of vaccination site bandages over time among both vaccinia-naive and vaccinia-experienced volunteers with respect to recovery of vaccinia, reactogenicity, tolerability, and ease of use.After vaccination, each volunteer was randomized to receive 1 of 3 types of vaccination site bandage: a 5#5-cm gauze bandage (curity gauze sponges sterile) attached with a single strip of adhesive tape, a 6.5#5-cm semipermeable occlusive bandage with a gauze lining (opsite post-op), or a 7.5#7.5-cm foam hydrocellular bandage (allevyn adhesive).It was reported that the use of the allevyn dressing was more likely to fall off prematurely and leaked onto clothing.

• Brand Name: UNKNOWN ALLEVYN
• 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: 9896202
• MDR Text Key: 185902068
• Report Number: 8043484-2020-00229
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2021
• 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