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..
[64271720]
Patient Sequence No: 1, Text Type: N, H10
[64271721]
Patient was seen in (b)(6) and casted (cast called tcc ez). The patient returned today for a follow up appointment and his rn reported that prior to removal of cast, patient complained the cast was "soft. " the patient proceeded to say that he did not call to report it because he did not want to "bother us. " the cast was removed and 2 injuries/new wounds located to the right lower leg. It was determined that our lot of casts were defective. Derma sciences was notified immediately and remaining casts were collected and swapped for a new batch. The manager from derma sciences will be issuing a product complaint report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6236244 |
| MDR Report Key | 6236244 |
| Date Received | 2017-01-10 |
| Date of Report | 2016-12-06 |
| Date of Event | 2016-12-01 |
| Report Date | 2016-12-06 |
| Date Reported to FDA | 2016-12-06 |
| Date Reported to Mfgr | 2016-12-06 |
| 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 | 1115013 |
| Device Expiration Date | 2017-07-08 |
| Device Availability | N |
| 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 |