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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. UNKNOWN ALLEVYN GENTLE (GENERATION II) DRESSING, WOUND, OCCLUSIVE

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SMITH & NEPHEW MEDICAL LTD. UNKNOWN ALLEVYN GENTLE (GENERATION II) DRESSING, WOUND, OCCLUSIVE Back to Search Results
Lot Number UNKNOWN
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/26/2020
Event Type  malfunction  
Event Description
It was reported that on removal of the plastic cover of two new allevyn gentle border dressings, part of the silicone came away from the foam and remained on the plastic cover. Additionally, on removal of an allevyn gentle heel placed on the patient's skin to treat pressure ulcer, bits of silicone remained on the skin and had to be picked off. It is unknown if a back-up was available and if there was a delay in the procedure. No patient harm reported.
 
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Brand NameUNKNOWN ALLEVYN GENTLE (GENERATION II)
Type of DeviceDRESSING, WOUND, OCCLUSIVE
Manufacturer (Section D)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull east riding of yorkshire HU3 2 BN
UK HU3 2BN
Manufacturer (Section G)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull east riding of yorkshire HU3 2 BN
UK HU3 2BN
Manufacturer Contact
sarah freestone
hessle road 101
hull
UK   HU3 2BN
0447940038
MDR Report Key10246381
MDR Text Key198098455
Report Number8043484-2020-01765
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot NumberUNKNOWN
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 Received03/09/2021
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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