FDA Adverse Event
Other
Summary report: N
PERCUGUIDE (20 GA. X 3 CM.)
MDR report key: 381102
·
Received March 6, 2002
Report
- Report Number
- 2411512-2002-00005
- Event Type
- Other
- Date Received
- March 6, 2002
- Date of Event
- January 30, 2002
- Report Date
- January 31, 2002
- Manufacturer
- MANAN MEDICAL PRODUCTS, INC.
- Product Code
- GDF
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
FACILITY REPORTED THAT THE NEEDLE TIP BROKE OFF DURING SURGERY. SURGEON WORKED FOR ABOUT 45 MINUTES TRYING TO LOCATE THE BROKEN TIP, BUT THE PATIENT'S REPORT SEEMED TO INDICATE THAT IT COULD NOT BE FOUND AND WAS LEFT INSIDE. PLAN WAS SET UP WITH THE PATIENT TO RE-X-RAY AFTER THE INCIDENT. INCIDENT RESULTED IN ADDITIONAL TISSUE BEING REMOVED, ADDITIONAL RADIATION, AND ADDITIONAL CHARGING TO PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PERCUGUIDE (20 GA. X 3 CM.) | LESION MARKING SYSTEM | GDF | MANAN MEDICAL PRODUCTS, INC. | NA | M10149901 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Other |