FDA Adverse Event
Malfunction
Summary report: N
RONGUER, IVD CUSHING
MDR report key: 6237744
·
Received January 6, 2017
Report
- Report Number
- MW5067150
- Event Type
- Malfunction
- Date Received
- January 6, 2017
- Date of Event
- January 4, 2017
- Report Date
- January 6, 2017
- Manufacturer
- BD/ V. MUELLER
- Product Code
- HAE
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
INFORMATION PROVIDED STATES: PITUITARY RONGEUR BROKE WHILE DISSECTING AND FELL IN WOUND. SURGEON WAS ABLE TO REVIEW THE PIECE OF INSTRUMENTATION. (THIS IS AN FYI, AS APPARENTLY THESE DO BREAK, BUT WE WANTED TO MAKE SURE YOU WERE AWARE IN CASE THERE IS A PROBLEM WITH BREAKAGE.)
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 13756 | RONGUER, IVD CUSHING | RONGUER, IVD CUSHING | HAE | BD/ V. MUELLER | VINV03 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR |