MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-10-19 for TCC-EZ CASTING SYSTEM 3" SINGLE APPLICATION TCC23002 manufactured by Derma Sciences, Inc..
[124477232]
To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
[124477233]
1 of 3 reports. Other mfg report numbers: 9680091-2018-00029, 9680091-2018-00030. "casting systems received over the past month are malfunctioning. The casting systems are going onto different patients. Approximately 7 patients have had additional wounds (diabetic ulcers) created due to casting systems issues, some were required to go to the emergency room to have casts cut off outside of wound center business hours. Approximately 20 casting systems are breaking down at the top of the ankle and front of the foot causing the need for reapplication. " additional information received confirms that 3 patients developed new wounds from the cast, not 7 originally reported. This reports is for a (b)(6) male, the reason for cast was diabetic foot ulcer. The injury is healing slowly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680091-2018-00028 |
| MDR Report Key | 7985610 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-10-19 |
| Date of Report | 2018-09-25 |
| Date Mfgr Received | 2018-10-11 |
| Date Added to Maude | 2018-10-19 |
| 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 CASTING SYSTEM 3" SINGLE APPLICATION |
| Generic Name | TCC-EZ |
| Product Code | ITG |
| Date Received | 2018-10-19 |
| Catalog Number | TCC23002 |
| Lot Number | 0618028 |
| 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 | 2018-10-19 |