FDA Adverse Event
Malfunction
Summary report: N
HOUSE STAPES CURETTE, 6" DOUBLE-ENDED, 2MMX2.5MM
MDR report key: 555792
·
Received November 18, 2004
Report
- Report Number
- 2430952-2004-00031
- Event Type
- Malfunction
- Date Received
- November 18, 2004
- Report Date
- November 18, 2004
- Manufacturer
- HEBU MEDICAL GMBH
- Product Code
- JYG
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- MN, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
THE CUPPED END OF THE CURETTE BROKE OFF IN THE PT'S EAR. THE BROKEN PIECE WAS RETRIEVED. NO HARM WAS REPORTED TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HOUSE STAPES CURETTE, 6" DOUBLE-ENDED, 2MMX2.5MM | EAR/NOSE INSTRUMENT | JYG | HEBU MEDICAL GMBH | * | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |