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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN LIFE N-BRDR 10X20 10 DRESSING,WOUND,OCCLUSIVE

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SMITH & NEPHEW MEDICAL LTD. ALLEVYN LIFE N-BRDR 10X20 10 DRESSING,WOUND,OCCLUSIVE Back to Search Results
Catalog Number 66801751
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Local Reaction (2035); Injury (2348)
Event Date 11/07/2017
Event Type  Injury  
Manufacturer Narrative
Device was not evaluated due to the sample was not returned for investigation. (b)(4).
 
Manufacturer Narrative
[(b)(4)].
 
Event Description
No treatment needed for excoriation as yet apart from moisturising.
 
Event Description
It was reported that a patient had taken an allergic reaction to the dressings that were on his legs. The legs had excoriated exactly to the size and margins of the dressings, and was proving quite painful to the patient.
 
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Brand NameALLEVYN LIFE N-BRDR 10X20 10
Type of DeviceDRESSING,WOUND,OCCLUSIVE
Manufacturer (Section D)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull HU3 2 8N
UK HU3 28N
Manufacturer (Section G)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull HU3 2 8N
UK HU3 28N
Manufacturer Contact
markus poettker
schachenallee 29
aarau 5001
SZ   5001
MDR Report Key7021081
MDR Text Key106651625
Report Number8043484-2017-00279
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number66801751
Device Lot Number1648
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/07/2017
Was Device Evaluated by Manufacturer? No
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: 11/10/2017 Patient Sequence Number: 1
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