inforMED
InjuryING

SCALAMOBIL

Received Dec 5, 2022 · Event occurred Nov 7, 2022

Report 3004730072-2022-00007 · MDR key 15915382

Device

Generic name

Scalamobil

Manufacturer

Alber Gmbh

Model number

S38

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