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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN GB MULTISITE CTN 5 DRESSING,WOUND,OCCLUSIVE

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SMITH & NEPHEW MEDICAL LTD. ALLEVYN GB MULTISITE CTN 5 DRESSING,WOUND,OCCLUSIVE Back to Search Results
Catalog Number 66800959
Device Problem Insufficient Information (3190)
Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)
Event Date 07/24/2019
Event Type  Injury  
Event Description
It was reported that there was an enlargement of ulcer due to exudate.
 
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Brand NameALLEVYN GB MULTISITE CTN 5
Type of DeviceDRESSING,WOUND,OCCLUSIVE
Manufacturer (Section D)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull
UK
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
0447940038
MDR Report Key8904481
MDR Text Key154686700
Report Number8043484-2019-00582
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K112127
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 11/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number66800959
Device Lot Number201844
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 Received11/28/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/18/2019 Patient Sequence Number: 1
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