FDA Adverse Event
Injury
Summary report: N
NOVA ZOOM ROLLATOR
MDR report key: 8565300
·
Received April 29, 2019
Report
- Report Number
- MW5086271
- Event Type
- Injury
- Date Received
- April 29, 2019
- Manufacturer
- NOVA ORTHO-MED, INC.
- Product Code
- ITJ
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- NO INFORMATION
Narratives
Description of Event or Problem · 1
SHE LOST HER BALANCE AND FELL. WHEN SHE FELL SHE LANDED ON ROLLATOR AND BROKE ROLLATOR. HURT BACK BUT RECOVERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 356539 | NOVA ZOOM ROLLATOR | WALKER, MECHANICAL | ITJ | NOVA ORTHO-MED, INC. | 4222DB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Other |