MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-04-25 for TCC-EZ CASE OF 10 CASTING SYSTEMS 4" NO BOOT TCC24001 manufactured by Derma Sciences, Inc..
[143055987]
The device was not yet 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.
Patient Sequence No: 1, Text Type: N, H10
[143055988]
A facility reported that a tcc cast (id tcc24001 / lot 18400075) caused a wound on the patient due to friction for a diabetic foot ulcer treatment. The resin is not hardening on the top or bottom, it stays soft, causing the friction. The wound was documented by the physician as follows: l dorsal foot, measuring 3. 0cm x 2cm x 0. 3cm d. Consecutive visits on march 18 and 21 showed slight improvement of 3. 0cm x 1. 5cm x 0. 2cm d and on april 11, the wound measured 2. 5cm x 1. 5cm x 0. 2cm d, showing slow but progressive improvement to the l dorsal foot. The current treatment is application of medihoney gel and absorbent cover dressing every day when needed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680091-2019-00005 |
| MDR Report Key | 8549261 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-04-25 |
| Date of Report | 2019-03-21 |
| Date Mfgr Received | 2019-05-17 |
| Date Added to Maude | 2019-04-25 |
| 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 CASE OF 10 CASTING SYSTEMS 4" NO BOOT |
| Generic Name | TCC-EZ |
| Product Code | ITG |
| Date Received | 2019-04-25 |
| Returned To Mfg | 2019-04-16 |
| Catalog Number | TCC24001 |
| Lot Number | 18400075 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-04-25 |