MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-05-04 for ULTRA-DRIVE UNK * manufactured by Biomet.
[21330142]
Initially it would not work and it was turned off and back on and worked for less than one minute before it quit again. The temperature indicator and a second indicator light were on the whole time even after being turned on and off. The rep was on the phone with myself while we were attempting to get the equipment to work. He was unable to redirect us as far as solving the problem off sight, so the attempt was stopped.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4784136 |
| MDR Report Key | 4784136 |
| Date Received | 2015-05-04 |
| Date of Report | 2015-05-04 |
| Date of Event | 2015-04-29 |
| Report Date | 2015-05-04 |
| Date Reported to FDA | 2015-05-04 |
| Date Reported to Mfgr | 2015-05-20 |
| Date Added to Maude | 2015-05-20 |
| 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 | 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 | ULTRA-DRIVE |
| Generic Name | SYSTEM, BONE |
| Product Code | JXE |
| Date Received | 2015-05-04 |
| Model Number | UNK |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET |
| Manufacturer Address | 56 EAST BELL DRIVE P.O BOX 587 WARSAW IN 46581 US 46581 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-04 |