FDA Adverse Event
Injury
Summary report: N
EITHER HAWKINS III OR KOPANS SPRING HOOK
MDR report key: 517980
·
Received March 23, 2004
Report
- Report Number
- 517980
- Event Type
- Injury
- Date Received
- March 23, 2004
- Date of Event
- March 3, 2004
- Report Date
- March 22, 2004
- Manufacturer
- KOPANS - COOK, INC
- Product Code
- MIJ
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- CT, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PT HAD SENTINEL NODE BREAST BIOPSY IN 2003. LOCALIZATION WIRE WAS RETAINED AT THAT TIME IN PLEURAL CAVITY. PT HAD SURGERY IN 2004 FOR REMOVAL OF WITH WIRE WHICH MIGRATED INTO NECK. PT DISCHARGED THE FOLLOWING DAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EITHER HAWKINS III OR KOPANS SPRING HOOK | LOCALIZATION NEEDLE | MIJ | KOPANS - COOK, INC | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Required Intervention |