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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 Problems Moisture Damage (1405); Appropriate Term/Code Not Available (3191)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 08/15/2017
Event Type  malfunction  
Manufacturer Narrative
The associated complaint device wa not returned for evaluation. (b)(4).
 
Event Description
It was reported during a demo fluid test for the product. The product absorbed the fluid over two minutes. The product was checked after 15 minutes and the pad was soaking wet and the fluid could be squeezed out easily.
 
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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 BN
UK HU3 2BN
Manufacturer (Section G)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull HU3 2 BN
UK HU3 2BN
Manufacturer Contact
markus poettker
scachenallee 29
aarau 5001
SZ   5001
MDR Report Key6819748
MDR Text Key165008982
Report Number8043484-2017-00223
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/17/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/25/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number66801751
Device Lot Number1648
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/15/2017
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

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