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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE BORDER 7.5X7.5CM INT DRESSING,WOUND,OCCLUSIVE

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SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE BORDER 7.5X7.5CM INT DRESSING,WOUND,OCCLUSIVE Back to Search Results
Catalog Number 66800269
Device Problem Material Disintegration (1177)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/29/2020
Event Type  malfunction  
Event Description
It was reported that on removal of the sacral dressing, some particles of silicone remained on the patient's skin surrounding the wound. On removal of the 15x15cm dressing, again, some particles of silicone remained on the patient's skin surrounding the wound. The wounds were both cavities and there was risk the silicone could end up in the wounds. These occurred on different patients, on different wards and different sites within the trust. On opening a new dressing 7. 5x7. 5cm, parts of the silicone remained on the film cover. It is unknown how many patients are involved. No patient harm reported.
 
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Brand NameALLEVYN GENTLE BORDER 7.5X7.5CM INT
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 Key10376605
MDR Text Key201990395
Report Number8043484-2020-02317
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/31/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number66800269
Device Lot NumberUNKNOWN
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 Received10/30/2020
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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