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

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.

• Brand Name: TRIPLE CARE EPC/EPB
• Type of Device: SECURA 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 Key: 5369230
• MDR Text Key: 36025369
• Report Number: 3006760724-2016-00001
• Device Sequence Number: 0
• Product Code: NEC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• 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 Received: 01/15/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2018
• Device Model Number: GB59432500
• Device Catalogue Number: GB59432500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/30/2015
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability