MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-04-04 for TCC-EZ UNKNOWN XXX-TCC-EZ manufactured by Derma Sciences, Inc..
[104365974]
The device will not be returned to the manufacturer for analysis. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation. Linked to sus voluntary event report (foi for manufacturers) number: mw5075511.
Patient Sequence No: 1, Text Type: N, H10
[104365975]
It was reported via medwatch number mw5075511 that infection occurred. On (b)(6) 2016, a patient went to the hyoerbarics and wound care center for a broken blister on the left. Subsequently, the physician placed a tcc-ez cast on the leg with an accompanying boot. During the initial visit, there were no infection noted by the physician. Two days post procedure, the cast was removed and imaging tests were done to check for the leg's circulation and the result was satisfactory. The physician reapplied the tcc-ez cast on the leg. The patient went back to the wound center and the cast was removed. However, the wound on the foot was severely infected with a noticeable odor. The patient was prescribed with an oral antibiotic and was scheduled for a bone scan. The next morning, the patient was noted to be in trouble and was taken to the emergency room at the memorial hospital. The infection was so severe. Three toes from the infected foot were removed by the surgeon. Additionally, the 4th toe and more on the part of the foot were removed and subsequently, the physician amputated the leg below the knee. No further patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680091-2018-00012 |
| MDR Report Key | 7396810 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-04-04 |
| Date of Report | 2018-03-19 |
| Date of Event | 2016-02-04 |
| Date Mfgr Received | 2018-05-08 |
| Date Added to Maude | 2018-04-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER VIVIAN NELSON |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | DERMA SCIENCES, INC. |
| Manufacturer Street | 104 SHORTING ROAD |
| Manufacturer City | TORONTO, ONTARIO M1S 3S4 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | M1S 3S4 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TCC-EZ UNKNOWN |
| Generic Name | TCC-EZ |
| Product Code | ITG |
| Date Received | 2018-04-04 |
| Catalog Number | XXX-TCC-EZ |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DERMA SCIENCES, INC. |
| Manufacturer Address | 104 SHORTING ROAD 104 SHORTING ROAD TORONTO, ONTARIO M1S 3S4 CA M1S 3S4 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Deathisabilit | 2018-04-04 |