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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. REPLICARE THIN DRESS 3.5X5.5IN DRESSING,WOUND,OCCLUSIVE

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SMITH & NEPHEW MEDICAL LTD. REPLICARE THIN DRESS 3.5X5.5IN DRESSING,WOUND,OCCLUSIVE Back to Search Results
Model Number 59484100
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Erosion (2075)
Event Date 07/15/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during wound treatment with replicare thin dress 3. 5x5. 5in, on follow up visit, substantial excoriation was noted on one patient. The usage of the dressing was suspended immediately. The treatment was completed using a vac therapy, and the patient received steroids and antifungal oral medications to treat the excoriation. No other complications were reported.
 
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Brand NameREPLICARE THIN DRESS 3.5X5.5IN
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 Key12725470
MDR Text Key279249845
Report Number8043484-2021-01918
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number59484100
Device Catalogue Number59484100
Device Lot NumberC2007241
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received01/26/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/24/2020
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: 10/30/2021 Patient Sequence Number: 1
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