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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW MEDICAL LTD. UNKN ALLEVYN LIFE DRESSING,WOUND,OCCLUSIVE Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Ulcer (2274); Impaired Healing (2378)
Event Date 12/28/2020
Event Type  Injury  
Manufacturer Narrative
Internal reference number case-(b)(4).
 
Event Description
On the literature article named " silicone adhesive multilayer foam dressings as adjuvant prophylactic therapy to prevent hospital-acquired pressure ulcers: a pragmatic noncommercial multicentre randomized open-label parallel-group medical device trial" it was reported that during treatment with an unknown allevyn life dressing to prevent pressure ulcer formation, from a total of 539 patients, a patient developed a pressure ulcer in an unspecified body region. Dressing was removed and treatment of the pressure ulcer was concluded according to the hospital's wound care protocol.
 
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Brand NameUNKN ALLEVYN LIFE
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
austin, TX 78735
5123913905
MDR Report Key12370111
MDR Text Key268220539
Report Number8043484-2021-01695
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Literature,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/05/2021
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: 08/26/2021 Patient Sequence Number: 1
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