FDA Adverse Event
Injury
Summary report: N
EURO-MED
MDR report key: 444310
·
Received February 18, 2003
Report
- Report Number
- 1216677-2002-00011
- Event Type
- Injury
- Date Received
- February 18, 2003
- Date of Event
- November 15, 2002
- Report Date
- February 18, 2003
- Manufacturer
- COOPERSURGICAL, INC.
- Product Code
- EME
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
BIOPSY PUNCH TIP BROKE OFF INSIDE THE PATIENT. THE DOCTOR HAD TO REMOVE THE BROKEN PIECE MANUALLY (FORCEPS OR FINGERS). THERE WAS NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EURO-MED | KEVORKIAN BIOPSY TIP | EME | COOPERSURGICAL, INC. | 64-488 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |