FDA Adverse Event
Other
Summary report: N
HUMI
MDR report key: 505921
·
Received January 8, 2004
Report
- Report Number
- 1216677-2003-00019
- Event Type
- Other
- Date Received
- January 8, 2004
- Date of Event
- November 6, 2003
- Report Date
- January 7, 2004
- Manufacturer
- COOPERSURGICAL, INC.
- Product Code
- LKF
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
DURING A PROCEDURE, DEVICE BROKE INSIDE THE PT. BROKEN PIECE WAS REMOVED BY FORCEPS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUMI | UTERINE MANIPULATOR/INJETOR | LKF | COOPERSURGICAL, INC. | 6001 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |