FDA Adverse Event
Malfunction
Summary report: N
V. MUELLER
MDR report key: 1932673
·
Received December 15, 2010
Report
- Report Number
- MW5018606
- Event Type
- Malfunction
- Date Received
- December 15, 2010
- Date of Event
- December 7, 2010
- Report Date
- December 14, 2010
- Manufacturer
- CAREFUSION
- Product Code
- KBN
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DR PLACED MCIVOR MOUTH GAG IN PT'S MOUTH. THE MAYO STAND WAS BROUGHT IN OVER PT'S CHEST AND MOUTH GAG ATTACHED. MAYO STAND WAS ELEVATED TO PROVIDE TRACTION AND EXPOSE TONSILS. THE MCIVOR MOUTH GAG BROKE AT WELD UPON ELEVATION AND EXPOSURE WAS LOST. NO INJURY TO PT. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | V. MUELLER | MCIVOR MOUTH GAG | KBN | CAREFUSION | MO 156 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR |