FDA Adverse Event
Injury
Summary report: N
COUNTER SINK GUIDE
MDR report key: 86725
·
Received April 25, 1997
Report
- Report Number
- MW1011210
- Event Type
- Injury
- Date Received
- April 25, 1997
- Date of Event
- April 11, 1997
- Report Date
- April 17, 1997
- Manufacturer
- OSTEOMED CORP.
- Product Code
- HWW
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- AZ, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
WHILE USING THE SELF-GUIDED COUNTER SINK, THE DR NOTICED THAT THE 1/8" LONG TIP HAD BROKEN OFF IN THE PT'S FOOT. AFTER SUCTIONING THE AREA EXTENSIVELY, THE PIECE OF METAL WAS RETRIEVED FROM THE SUCTION CANISTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COUNTER SINK GUIDE | COUNTER SINK GUIDE | HWW | OSTEOMED CORP. | 320-0024 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Required Intervention |