FDA Adverse Event
Malfunction
Summary report: N
AUDIO EFFECTS GENERATOR
MDR report key: 29204
·
Received January 2, 1996
Report
- Report Number
- MW4000841
- Event Type
- Malfunction
- Date Received
- January 2, 1996
- Report Date
- April 12, 1995
- Manufacturer
- BGC ENTERPRISES, INC.
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Description of Event or Problem · 1
BGC ENTERPRISES, INC. 4721 MURAT PLACE, SAN DIEGO, CA 92117. THE DEVICE REFERENCED ON THIS REPORT "AUDIOKINETRON" IS NOT OUR PRODUCT NOR IS IT MFG BY THIS CO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUDIO EFFECTS GENERATOR | AUDIO EFFECTS GENERATOR | BGC ENTERPRISES, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |