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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIPLE CARE EPC/EPB SECURA EXTRA PROT CRM 7.75OZ

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SMITH & NEPHEW, INC. TRIPLE CARE EPC/EPB SECURA EXTRA PROT CRM 7.75OZ Back to Search Results
Model Number GB59432500
Device Problem Insufficient Information (3190)
Patient Problems Erythema (1840); Reaction (2414)
Event Date 12/23/2015
Event Type  Injury  
Manufacturer Narrative
 
Event Description
Adverse skin reaction a report of erythema and skin slushing off and peeling within three days of application. Treatment was stopped immediately and cream applied. The skin is no longer red and peeling.
 
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Brand NameTRIPLE CARE EPC/EPB
Type of DeviceSECURA EXTRA PROT CRM 7.75OZ
Manufacturer (Section D)
SMITH & NEPHEW, INC.
101 hessle road
hull HU3 2 BN
UK HU3 2BN
Manufacturer (Section G)
SMITH & NEPHEW, INC.
101 hessle road
hull HU5 3 BN
UK HU5 3BN
Manufacturer Contact
claudia odoy
schachenallee 29
aarau 5001
SZ   5001
MDR Report Key5369230
MDR Text Key36025369
Report Number3006760724-2016-00001
Device Sequence Number0
Product Code NEC
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/30/2015
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received01/15/2016
Is this an Adverse Event Report? Yes
Device Operator
Device Expiration Date01/31/2018
Device Model NumberGB59432500
Device Catalogue NumberGB59432500
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 Received12/30/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 01/15/2016 Patient Sequence Number: 1
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