TCC-EZ (TOTAL CONTACT CAST)

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-23 for TCC-EZ (TOTAL CONTACT CAST) manufactured by Integra Life Sciences (formerly Derma Sciences).

Event Text Entries

[101068973] On (b)(6) 2016 i went to the hyperbarics and wound care center ((b)(6)) in (b)(6) for a broken blister on my left foot. The doctor (dr. (b)(6)) placed the tcc-ez cast on my leg with an accompanying boot. Two days later ((b)(6) 2016) i went back to the doctor; he removed the cast and sent me to an imaging center for tests to check the circulation in my legs. That same afternoon i went back to the doctor. As the circulation in my legs was satisfactory, he reapplied the tcc-ez cast to my leg. On (b)(6) 2016 i went back to the wound center. The doctor removed the cast, and the wound on my foot was severely infected with a noticeable foul odor. The doctor sent me home with an oral antibiotic, scheduling a bone scan for (b)(6) 2016. The next morning ((b)(6) 2016) my caregiver ((b)(6)) knew i was in trouble. He took me to the emergency room at (b)(6) memorial hospital in (b)(6). The infection was so severe, late that afternoon a vascular surgeon removed 3 toes and part of my foot. On (b)(6) 2016, he removed a 4th toe and more of my foot. On (b)(6) 2016, he amputated my leg below the knee. There was no infection (according to the doctor) in my foot wound at initial visit.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5075511
• MDR Report Key: 7295946
• Date Received: 2018-02-23
• Date of Report: 2018-02-16
• Date of Event: 2016-02-04
• Date Added to Maude: 2018-02-26
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: TCC-EZ (TOTAL CONTACT CAST)
• Generic Name: TCC-EZ (TOTAL CONTACT CAST)
• Product Code: IPG
• Date Received: 2018-02-23
• Operator: LAY USER/PATIENT
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: INTEGRA LIFE SCIENCES (FORMERLY DERMA SCIENCES)

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Life Threatening; 3. Deathisabilit	2018-02-23