FDA Adverse Event
Malfunction
Summary report: N
CRS CUT FISR BUR
MDR report key: 148569
·
Received February 6, 1998
Report
- Report Number
- 1811755-1998-00005
- Event Type
- Malfunction
- Date Received
- February 6, 1998
- Report Date
- January 19, 1998
- Manufacturer
- STRYKER INSTRUMENTS
- Product Code
- EJL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PRODUCTS KEEPS BREAKING, CUSTOMER FEELS POSSIBLE BAD LOT. REPLACED 100 2296-100-221.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CRS CUT FISR BUR | BUR | EJL | STRYKER INSTRUMENTS | 2296-100-221 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |