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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN ADH 12.5X12.5CM CTN 10 DRESSING,WOUND,OCCLUSIVE

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SMITH & NEPHEW MEDICAL LTD. ALLEVYN ADH 12.5X12.5CM CTN 10 DRESSING,WOUND,OCCLUSIVE Back to Search Results
Catalog Number 66000044
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Injury (2348)
Event Date 03/20/2020
Event Type  Injury  
Event Description
It was reported that the sponge surface that protects the wound was stuck to the skin and also to the wound, causing a lot of pain. No injury reported but the skin has been badly damaged.
 
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Brand NameALLEVYN ADH 12.5X12.5CM CTN 10
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
0628320660
MDR Report Key9992025
MDR Text Key188706243
Report Number8043484-2020-00313
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
K945330
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number66000044
Device Lot Number201724
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 Received07/21/2020
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 Treatment Data
Date Received: 04/23/2020 Patient Sequence Number: 1
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