FDA Adverse Event
Injury
Summary report: N
HOVEROUND
MDR report key: 22883867
·
Received August 25, 2025
Report
- Report Number
- 1056601-2025-00005
- Event Type
- Injury
- Date Received
- August 25, 2025
- Date of Event
- April 17, 2025
- Report Date
- May 19, 2025
- Manufacturer
- HOVEROUND
- Product Code
- ITI
- UDI-DI
- 00859781000019
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THE CLIENT STATES THE SORES BECAME INFECTED AND CLIENT NEEDED TO BE HOSPITALIZED FOR WOUND CARE AND THEN FOLLOW UP WITH REHAB. DUE TO SERIOUSNESS OF THE INJURY HOVEROUND FELT IT WAS BEST TO REPORT.
Description of Event or Problem · 0
CLIENT STATES WHEN SHE GETS IN OR OUT OF PWC, THE FOOTPLATE FALLS DOWN AND HITS THE FRONT OF HER LEGS BELOW THE KNEE, ON THE SHINS. CLIENT STATES SHE HAS LARGE SORES AND THIS HAS MADE HER WEAK TO THE POINT SHE IS UNABLE TO TRANSFER, AMBULANCE WAS CALLED AND SHE WAS TAKE TO HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2390947 | HOVEROUND | MOTORIZED WHEELCHAIR | ITI | HOVEROUND | MPV5 | 00859781000019 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Female | Hospitalization |