MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-11-21 for TCC-EZ CASTING SYSTEM 3" SINGLE APPLICATION TCC23002 manufactured by Derma Sciences, Inc..
[128317021]
The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
[128317022]
It was reported that the tcc-ez casting system was placed on the patient and did not get hard after waiting 30 minutes. The physician and nurse then had to reinforce the cast with fiberglass tape. 5 of 5 reports - other mfg report numbers: 9680091-2018-00034, 9680091-2018-00035, 9680091-2018-00036, 9680091-2018-00037.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680091-2018-00038 |
| MDR Report Key | 8096708 |
| Report Source | USER FACILITY |
| Date Received | 2018-11-21 |
| Date of Report | 2018-11-07 |
| Date Mfgr Received | 2018-11-23 |
| Date Added to Maude | 2018-11-21 |
| 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 | 2018-11-21 |
| Catalog Number | TCC23002 |
| Lot Number | 0218016 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2018-11-21 |