FDA Adverse Event
Malfunction
Summary report: N
PHASOR DRILL
MDR report key: 19739716
·
Received July 15, 2024
Report
- Report Number
- 19739716
- Event Type
- Malfunction
- Date Received
- July 15, 2024
- Date of Event
- February 21, 2024
- Report Date
- February 23, 2024
- Manufacturer
- PHASOR HEALTH, LLC
- Product Code
- HBE
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MO
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
DRILL DID NOT WORK WHEN TAKEN OUT OF BOX. DEAD BATTERY SUSPECTED. NEW DRILL OBTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1391287 | PHASOR DRILL | DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) | HBE | PHASOR HEALTH, LLC | 5.3 | 231120530 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Male |