SCALAMOBIL
Received Dec 5, 2022 · Event occurred Nov 7, 2022
Report 3004730072-2022-00007 · MDR key 15915382
Device
Product problems
- Device Fell
Patient
Unknown
- Bruise/Contusion
- Bruise/Contusion
Narrative
Description of Event or Problem
ALLEGEDLY ON THE (B)(6) 2022 THE EVENT OCCURRED ON THE HALF OF THE STAIRCASE IN THE DOWNWARD MOVEMENT IN A CURVE. THE DEVICE WAS OPERATED BY THE MOTHER. THERE WAS A CLACKING SOUND BEFOREHAND, AFTER WHICH THE BRAKES ON THE EDGE OF THE STAIR STEP DID NOT WORK. THE MOTHER (OPERATOR), THE SCALAMOBIL AND THE CHILD, FELL DOWN THE REMAINING STEPS. THE CHILD DID NOT SUFFER ANY INJURIES. THE MOTHER HERSELF WAS TREATED AS AN INPATIENT AT THE HOSPITAL AND A RIGHT WRIST CONTUSION WAS DETECTED.
Additional Manufacturer Narrative
THIS EVENT OCCURED IN GERMANY. ALBER GMBH IS FILING THIS REPORT BEACUSE THE DEVICE IS MARKETED AND SOLD IN THE U.S. ALBER HAS REQUESTED THE INVOLVED DEVICE FOR INVESTIGATION AND FURTHER INFORMATION ON THE CIRCUMSTANCES OF THE EVENT.
Remedial action
- Inspection