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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW MEDICAL LTD. UNKN ALLEVYN GENTLE BORDER DRESSING,WOUND,OCCLUSIVE Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Purulent Discharge (1812); Erythema (1840); Blister (4537); Skin Inflammation/ Irritation (4545); Insufficient Information (4580)
Event Date 09/26/2021
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference case- (b)(4).
 
Event Description
It was reported that, during treatment of an infected wound with allevyn gentle border, the dressing kept everything in and the patient's leg exploded as pressure built. It is unknown how this was addressed afterwards. Patient outcome is unknown.
 
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Brand NameUNKN ALLEVYN GENTLE BORDER
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
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key12615424
MDR Text Key275895246
Report Number8043484-2021-01856
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 Foreign,Consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received02/22/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/12/2021 Patient Sequence Number: 1
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