FDA Adverse Event
Injury
Summary report: N
SCALAMOBIL S30 IQ
MDR report key: 14520636
·
Received May 27, 2022
Report
- Report Number
- 3004730072-2022-00003
- Event Type
- Injury
- Date Received
- May 27, 2022
- Date of Event
- March 16, 2022
- Report Date
- May 13, 2022
- Manufacturer
- ALBER GMBH
- Product Code
- ING
- PMA / PMN Number
- K920105
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THIS EVENT OCCURRED IN (B)(6). ALBER GMBH IS FILING THIS REPORT BECAUSE THE DEVICE IS MARKETED AND SOLD IN THE U.S. ALBER GMBH WILL START THE PHYSICAL EVALUATION OF THE INVOLVED DEVICE ONCE IT WILL ARRIVE AT OUR PREMISES.
Description of Event or Problem · 0
THE EVENT OCCURRED AT THE HOME OF A PATIENT. THE EVENT HAPPENED DURING THE TRANSFER OF THE PATIENT ON THE STAIRCASE. THE PATIENT FELL OUT OF THE WHEELCHAIR WHICH WAS ATTACHED TO THE SCALAMOBIL. THE PATIENT SUSTAINED INJURIES WHICH NECESSITATED MEDICAL TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1801998 | SCALAMOBIL S30 IQ | SCALAMOBIL S30 IQ | ING | ALBER GMBH | S30 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Hospitalization |