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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE 5CM X 5CM DRESSING, WOUND, OCCLUSIVE

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SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE 5CM X 5CM DRESSING, WOUND, OCCLUSIVE Back to Search Results
Catalog Number 66800247
Device Problems Nonstandard Device (1420); Material Integrity Problem (2978)
Patient Problems Erythema (1840); Itching Sensation (1943); Swelling/ Edema (4577)
Event Date 11/30/2020
Event Type  Injury  
Manufacturer Narrative
Complaint: (b)(4).
 
Event Description
It was reported that an allevyn gentle was used on the wound, once, for 12 hours. After that, the leg became swollen, there was severe itching and peeled redness. When removing the bandage, silicone remained in the wound and had to be removed. Its is unknown how the condition was treated.
 
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Brand NameALLEVYN GENTLE 5CM X 5CM
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 Key11038357
MDR Text Key222364479
Report Number8043484-2020-04325
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 03/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number66800247
Device Lot Number1926
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 Received02/25/2021
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

Patient Treatment Data
Date Received: 12/18/2020 Patient Sequence Number: 1
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