FDA Adverse Event
Injury
Summary report: N
BOSS CURETTE
MDR report key: 19595646
·
Received June 21, 2024
Report
- Report Number
- MW5156493
- Event Type
- Injury
- Date Received
- June 21, 2024
- Date of Event
- January 16, 2024
- Report Date
- June 19, 2024
- Manufacturer
- BOSS INSTRUMENTS, LTD.
- Product Code
- HTF
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- WV, US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
HEAD OF CURETTE BROKE OFF INTO JOINT OF LEFT ANKLE. THEN REMOVED AND NO FOREIGN BODY WAS LEFT. INSTRUMENT STERILIZED AND TAGGED AS BROKEN. BROKEN INSTRUMENT IN RISK MANAGEMENT OFFICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1157212 | BOSS CURETTE | CURETTE | HTF | BOSS INSTRUMENTS, LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Female | Required Intervention |