FDA Adverse Event
Summary report: N
MECHANICAL WALKER, ROLLATOR
MDR report key: 3061502
·
Received April 16, 2013
Report
- Report Number
- 1531186-2013-01583
- Date Received
- April 16, 2013
- Report Date
- March 20, 2013
- Manufacturer
- UNKNOWN
- Product Code
- ITJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
(B)(6) -THE DEALER REPORTED THAT THE 65650 ROLLATOR BRAKES WERE NOT HOLDING, AND THE TIRES WERE REPLACED IN AN ATTEMPT TO FIX THE ISSUE WITHOUT SUCCESS. THERE WAS NO INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 163617 | MECHANICAL WALKER, ROLLATOR | 890.3825 | ITJ | UNKNOWN | 65650 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |