FDA Adverse Event
Malfunction
Summary report: N
ACRA-CUT
MDR report key: 363938
·
Received November 30, 2001
Report
- Report Number
- MW1023513
- Event Type
- Malfunction
- Date Received
- November 30, 2001
- Date of Event
- September 7, 2001
- Report Date
- November 30, 2001
- Manufacturer
- ACRA CUT
- Product Code
- HBF
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
THE CLUTCH FAILED TO DISENGAGE AND IT ENTERED INTO THE DURA. NO INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 54030 | ACRA-CUT | PERFORATOR TIP | HBF | ACRA CUT | 200-271 | 4059 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |