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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW MEDICAL LTD. UNKNOWN ALLEVYN DRESSING,WOUND,OCCLUSIVE Back to Search Results
Catalog Number UNKNOWN
Device Problems Fluid 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.
 
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Brand NameUNKNOWN ALLEVYN
Type of DeviceDRESSING,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 Key9896202
MDR Text Key185902068
Report Number8043484-2020-00229
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received03/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/12/2021
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

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