FDA Adverse Event
Other
Summary report: N
AMERICAN MEDICAL SPECIALTIES
MDR report key: 771893
·
Received October 19, 2006
Report
- Report Number
- MW1040738
- Event Type
- Other
- Date Received
- October 19, 2006
- Date of Event
- April 21, 2006
- Report Date
- October 11, 2006
- Manufacturer
- SOURTHERN CARBIDE
- Product Code
- HTT
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE TIP OF A SURGICAL BUR PURCHASED FROM AMERICAN MEDICAL SPECIALTIES, INC. CAME OFF DURING A PROCEDURE INVOLVING DRILLING INTO THE PT'S BONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AMERICAN MEDICAL SPECIALTIES | WIRE PASS BUR | HTT | SOURTHERN CARBIDE | AZB-448 | 0803008 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Other |