FDA Adverse Event
Summary report: N
MECHANICAL WALKER, ROLLATOR
MDR report key: 3971491
·
Received July 31, 2014
Report
- Report Number
- 1531186-2014-02928
- Date Received
- July 31, 2014
- Report Date
- June 25, 2014
- Manufacturer
- UNKNOWN
- Product Code
- ITJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
PER CUSTOMER STATES THE REAR RIGHT WHEEL IS SPLIT/CRACKED IN TWO PLACES. SHE STATES SHE IS STILL USING THE PRODUCT. CUSTOMER IS UNAWARE OF HOW IT GOT DAMAGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 447425 | MECHANICAL WALKER, ROLLATOR | 890.3825 | ITJ | UNKNOWN | 66550 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |