MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-16 for TOTAL CONTACT CAST manufactured by Bsn Medical, Inc..
[183517440]
Two events with same issue: minor injury during cast removal with use of cast saw. Two separate users reported blade slipped when coming in contact with narrow removal guide/protector and came in contact with the skin during removal, causing injury. Users report difficulty with use due to the narrow guides/protectors.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9835079 |
| MDR Report Key | 9835079 |
| Date Received | 2020-03-16 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-02-06 |
| Report Date | 2020-02-25 |
| Date Reported to FDA | 2020-02-25 |
| Date Reported to Mfgr | 2020-03-16 |
| Date Added to Maude | 2020-03-16 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | TOTAL CONTACT CAST |
| Generic Name | INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL |
| Product Code | ITG |
| Date Received | 2020-03-16 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BSN MEDICAL, INC. |
| Manufacturer Address | 5825 CARNEGIE BLVD CHARLOTTE NC 28209 US 28209 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-16 |