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..
[128114909]
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
[128114910]
It was reported that a tcc-ez casting system caused a wound from the cast rubbing the skin. The cast was crinkled and the patient had to cut the boot off herself and when the cast was applied again in the office, it would not harden and it was very pliable. 3 of 5 reports: other mfg report numbers: 9680091-2018-00034, 9680091-2018-00035, 9680091-2018-00037, 9680091-2018-00038.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680091-2018-00036 |
| MDR Report Key | 8096733 |
| Report Source | USER FACILITY |
| Date Received | 2018-11-21 |
| Date of Report | 2018-11-06 |
| Date Mfgr Received | 2018-12-11 |
| 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 | 0318016 |
| 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 |