InjuryING
SCALAMOBIL S30 IQ
Received May 27, 2022 · Event occurred Mar 16, 2022
Report 3004730072-2022-00003 · MDR key 14520636
Device
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
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
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.
Remedial action
- Inspection