FDA Adverse Event
Summary report: N
MECHANICAL WALKER, ROLLATOR
MDR report key: 3212015
·
Received July 8, 2013
Report
- Report Number
- 1531186-2013-03021
- Date Received
- July 8, 2013
- Report Date
- June 14, 2013
- Manufacturer
- GENTEEL HOMECARE PRODUCTS
- Product Code
- ITJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
THE PROVIDER REPORTED THE LEFT SIDE OF THE 6291-JR WALKER WILL NOT LOCK INTO PLACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309346 | MECHANICAL WALKER, ROLLATOR | 890.3825 | ITJ | GENTEEL HOMECARE PRODUCTS | 6291-JR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |