FDA Adverse Event
Malfunction
Summary report: N
MECHANICAL WALKER, ROLLATOR
MDR report key: 3031643
·
Received April 2, 2013
Report
- Report Number
- 1525712-2013-02499
- Event Type
- Malfunction
- Date Received
- April 2, 2013
- Report Date
- March 6, 2013
- Manufacturer
- KENSTONE METAL
- Product Code
- ITJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4) - FOLLOW UP #001. INITIAL (B)(4) ISSUED MFR. REPORT # 1525712-2013-02499 INDICTING THE FOLLOWING: BRAND NAME AS A NON AC-POWERED PATIENT LIFT, CORRECTION IS A MECHANICAL WALKER, ROLLATOR; COMMON DEVICE NAME AS 880.5510, CORRECTION IS 890.3825: - MANUFACTURER AS INVACARE (B)(4), CORRECTION IS KENSTONE METAL; MODEL NUMBER AS UNKNOWN, CORRECTION IS 66550; SERIAL NUMBER AS (B)(4), CORRECTION IS (B)(4).
Description of Event or Problem · 1
DEALER STATES THE REAR WHEELS WERE BENT ON BOTH SIDES.
Description of Event or Problem · 1
.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 135127 | MECHANICAL WALKER, ROLLATOR | 890.3825 | ITJ | KENSTONE METAL | 66550 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |