MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-10-18 for AMERICAN ORTHOPEDIC CAST CUTTER 0295-200 * manufactured by Bsn Medical.
[513619]
Physical therapist was removing a lower extremity cast. The blade felt warm after a short period of time. The cast was removed in approx 20 to 30 second increments to allow cooling. When the cast was removed, a small reddened area was present on the pt 's r distal lateral tibial area. Antibiotic ointment was immediately applied. Md was notified. Dr requested tegaderm to be applied prior to recasting later in the day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1040748 |
| MDR Report Key | 772277 |
| Date Received | 2006-10-18 |
| Date of Report | 2006-10-18 |
| Date of Event | 2006-09-25 |
| Date Added to Maude | 2006-10-25 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMERICAN ORTHOPEDIC CAST CUTTER |
| Generic Name | CAST SAW |
| Product Code | LGG |
| Date Received | 2006-10-18 |
| Model Number | 0295-200 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 760061 |
| Manufacturer | BSN MEDICAL |
| Manufacturer Address | * CHARLOTTE NC * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2006-10-18 |