FDA Adverse Event
Malfunction
Summary report: N
BITESTICK
MDR report key: 22588
·
Received June 20, 1995
Report
- Report Number
- MW1006292
- Event Type
- Malfunction
- Date Received
- June 20, 1995
- Date of Event
- May 25, 1995
- Report Date
- June 9, 1995
- Manufacturer
- SAGE PRODUCTS, INC.
- Product Code
- JXL
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PT BIT A BITESTICK IN HALF AND GAGGED. PT TRIED TO VOMIT BECAUSE HALF OF STICK REMAINED IN MOUTH. PT WAS ABLE TO COUGH OUT THE RETAINED PORTION ON HER OWN. PT SUFFERED NO INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BITESTICK | BITESTICK | JXL | SAGE PRODUCTS, INC. | 1421 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR |