FDA Adverse Event
Summary report: N
MECHANICAL WALKER, ROLLATOR
MDR report key: 3073634
·
Received April 23, 2013
Report
- Report Number
- 1531186-2013-01725
- Date Received
- April 23, 2013
- Report Date
- March 28, 2013
- Manufacturer
- GENTEEL HOMECARE PRODUCTS
- Product Code
- ITJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
(B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PROVIDER STATES SEAT IS BROKEN. MDR FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 175107 | MECHANICAL WALKER, ROLLATOR | 890.3825 | ITJ | GENTEEL HOMECARE PRODUCTS | 68100-TA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |