MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-08-12 for V. MUELLER FREER RH750 * manufactured by Carefusion 2200, Inc..
[21267389]
Freer elevator broke off in the left foot during surgery and was recovered by the surgeon. No retained object or fragments noted in foot. No harm to patient or staff. Age of device is unknown. What was the original intended procedure? Removal of bone spur, kidner procedure with tp tendon advancement. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3294464 |
| MDR Report Key | 3294464 |
| Date Received | 2013-08-12 |
| Date of Report | 2013-08-12 |
| Date of Event | 2013-08-05 |
| Report Date | 2013-08-12 |
| Date Reported to FDA | 2013-08-12 |
| Date Reported to Mfgr | 2013-08-19 |
| Date Added to Maude | 2013-08-19 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| 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 | V. MUELLER FREER |
| Generic Name | ELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY |
| Product Code | GEG |
| Date Received | 2013-08-12 |
| Model Number | RH750 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION 2200, INC. |
| Manufacturer Address | 1500 WAUKEGAN ROAD WAUKEGAN IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-12 |