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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE BORDER LITE 10X10CM DRESSING,WOUND,OCCLUSIVE

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SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE BORDER LITE 10X10CM DRESSING,WOUND,OCCLUSIVE Back to Search Results
Catalog Number 66800835
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/20/2020
Event Type  malfunction  
Event Description
It was reported that the allevyn gentle border lite couldn't handle a large amount of liquid so there was a leakage. The patient is incontinent for urine and it cannot be ruled out that urine has come on the outside of the allevyn gentle border lite bandage.
 
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Brand NameALLEVYN GENTLE BORDER LITE 10X10CM
Type of DeviceDRESSING,WOUND,OCCLUSIVE
Manufacturer (Section D)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull
UK
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 Key9718584
MDR Text Key181661608
Report Number8043484-2020-00102
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
K063835
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 05/18/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number66800835
Device Lot Number201852
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/17/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2020
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

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