FDA Adverse Event
Malfunction
Summary report: N
LAPAROSCOPIC 5MM BABCOCK
MDR report key: 1970133
·
Received January 21, 2011
Report
- Report Number
- MW5019103
- Event Type
- Malfunction
- Date Received
- January 21, 2011
- Date of Event
- January 3, 2011
- Report Date
- January 7, 2011
- Manufacturer
- BRUDER HEALTHCARE COMPANY
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
WHILE MD WAS USING THE BABCOCK, IT BROKE WHILE INSIDE THE PT. NO HARM WAS DONE. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LAPAROSCOPIC 5MM BABCOCK | NONE | GCJ | BRUDER HEALTHCARE COMPANY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 0 DA |