TCC-EZ (TOTAL CONTACT CAST)
Received Feb 23, 2018 · Event occurred Feb 4, 2016
Report MW5075511 · MDR key 7295946
Device
Generic name
Tcc-ez (total Contact Cast)
Manufacturer
Integra Life Sciences (formerly Derma Sciences)Product problems
- Patient-Device Incompatibility
Patient
81 YR
- Unspecified Infection
- Post Operative Wound Infection
- Unspecified Infection
- Post Operative Wound Infection
Narrative
Description of Event or Problem
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.