FDA Adverse Event
Malfunction
Summary report: N
ADULT JUNIOR WALKLITE WALKER 9153643783
MDR report key: 4501875
·
Received February 10, 2015
Report
- Report Number
- 1531186-2015-00890
- Event Type
- Malfunction
- Date Received
- February 10, 2015
- Date of Event
- January 27, 2015
- Report Date
- February 3, 2015
- Manufacturer
- GENTEEL HOMECARE PRODUCTS
- Product Code
- ITJ
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- NY, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
DEALER REPORTED THAT THE SEAT ON A 6300-JRA CRACKED THEN BROKE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 99768 | ADULT JUNIOR WALKLITE WALKER 9153643783 | WALKER, MECHANICAL | ITJ | GENTEEL HOMECARE PRODUCTS | 6300-JRA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |