FDA Adverse Event
Summary report: N
MECHANICAL WALKER, ROLLATOR
MDR report key: 2563130
·
Received May 8, 2012
Report
- Report Number
- 1531186-2012-00200
- Date Received
- May 8, 2012
- Report Date
- May 2, 2012
- Manufacturer
- GENTEEL (MAXHEALTH)
- Product Code
- ITJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
CUSTOMER ALLEGED BOLT FOR WHEEL BROKE. NO INJURY ALLEGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MECHANICAL WALKER, ROLLATOR | 890.3825 | ITJ | GENTEEL (MAXHEALTH) | 65100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 | Other |