FDA Adverse Event
Malfunction
Summary report: N
JAY ACTIVE CUSHION
MDR report key: 74172
·
Received March 6, 1997
Report
- Report Number
- 1720745-1997-00002
- Event Type
- Malfunction
- Date Received
- March 6, 1997
- Report Date
- February 5, 1997
- Manufacturer
- JAY MEDICAL, LTD.
- Product Code
- FMP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE RETAIL DISTRIBUTOR REPORTED THAT THE FLUID PAD WAS HARDENDED. THE DEVICE INVOLVED IS AN OBSOLETE CONFIGURATION OF A CUSHION (WHEELCHAIR). THERE IS NO DEATH OR INJURY INVOLVED. UPON INVESTIGATION THE FLUID PAD WAS FOUND TO HAVE STIFFENED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JAY ACTIVE CUSHION | WHEELCHAIR CUSHION | FMP | JAY MEDICAL, LTD. | 121 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other | WHEELCHAIR |