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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
Model Number 66020412
Device Problems Material Discolored (1170); Ambient Noise Problem (2877)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/05/2021
Event Type  malfunction  
Event Description
It was reported that, during an advance wound management treatment an allevyn gentle border 7. 5 cm x 7. 5 cm was found to be stained blue and had brown foreign matter on it. Treatment was performed, without any delay, with a back-up device instead. Patient was not injured as consequence of this problem.
 
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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 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
MDR Report Key12057895
MDR Text Key258066429
Report Number8043484-2021-01557
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Reporter Country CodeKS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/01/2022
Device Model Number66020412
Device Catalogue Number66800269
Device Lot Number202028
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/24/2021 Patient Sequence Number: 1
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