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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. UNKN CUTICERIN

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SMITH & NEPHEW MEDICAL LTD. UNKN CUTICERIN Back to Search Results
Catalog Number UNKN05002000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Infection (4544)
Event Date 01/01/1901
Event Type  Injury  
Event Description
It was reported that, during burn treatment with a combination of an unknown cuticerin dressing and an unknown jelonet dressing, patient experienced an infection in the wound due to e. Coli. Patient was not satisfied with the reduction level on wound odor. As this was noticed in a retrospective post market clinical follow up activity, further information is not available.
 
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Brand NameUNKN CUTICERIN
Type of DeviceUNKN CUTICERIN
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 Key11891241
MDR Text Key252886118
Report Number8043484-2021-01234
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKN05002000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/15/2021
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

Patient Treatment Data
Date Received: 05/26/2021 Patient Sequence Number: 1
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