FDA Adverse Event
Summary report: N
MECHANICAL WALKER, ROLLATOR
MDR report key: 2890348
·
Received December 29, 2012
Report
- Report Number
- 1531186-2012-01903
- Date Received
- December 29, 2012
- Report Date
- December 28, 2012
- Manufacturer
- KENSTONE METAL
- Product Code
- ITJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
ON (B)(6) -THE DEALER REPORTED THAT THE 66550 ROLLATOR WHEEL OUTER COVER HAD SPLIT AND THE UNIT WAS WOBBLY. THERE WAS NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MECHANICAL WALKER, ROLLATOR | 890.3825 | ITJ | KENSTONE METAL | 66550 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 | Other |