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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYV LIFE 10.3CM X 10.3CM SAMPLE DRESSING,WOUND,OCCLUSIVE

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SMITH & NEPHEW MEDICAL LTD. ALLEVYV LIFE 10.3CM X 10.3CM SAMPLE DRESSING,WOUND,OCCLUSIVE Back to Search Results
Catalog Number 66801067
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/28/2020
Event Type  malfunction  
Event Description
It was reported that the product does not fully absorbing the exudate. It is unknown if there was a back up and how was the problem solved.
 
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Brand NameALLEVYV LIFE 10.3CM X 10.3CM SAMPLE
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
4407940038
MDR Report Key9732315
MDR Text Key181663587
Report Number8043484-2020-00117
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/26/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number66801067
Device Lot Number1910
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 Received03/20/2020
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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