MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-10 for TCC EZ CAST manufactured by Derma Sciences, Inc..
[64289166]
Patient Sequence No: 1, Text Type: N, H10
[64289167]
The patient was discharged by the physician with a "soft" cast. The physician stated the sides of the cast did not completely harden but the cast boot provides stability and it will be fine. The patient was phoned today (mid-(b)(6)) and asked to return to the center to have the cast evaluated. The patient was in agreement and placed on the schedule.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6236646 |
| MDR Report Key | 6236646 |
| Date Received | 2017-01-10 |
| Date of Report | 2016-12-07 |
| Date of Event | 2016-12-05 |
| Report Date | 2016-12-07 |
| Date Reported to FDA | 2016-12-07 |
| Date Reported to Mfgr | 2016-12-07 |
| Date Added to Maude | 2017-01-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TCC EZ CAST |
| Generic Name | BANDAGE, CAST |
| Product Code | ITG |
| Date Received | 2017-01-10 |
| Lot Number | 0816003 |
| Device Expiration Date | 2018-01-12 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DERMA SCIENCES, INC. |
| Manufacturer Address | 145 CASSENS CT. ST. LOUIS MO 63026 US 63026 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-10 |