MAUDE Adverse Event Report: ALBER GMBH SCALAMOBIL

Model Number S38

Device Problem Device Fell (4014)

Patient Problem Bruise/Contusion (1754)

Event Date 11/07/2022

Event Type  Injury  

Event Description

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.

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.

• Brand Name: SCALAMOBIL
• Type of Device: SCALAMOBIL
• Manufacturer (Section D): ALBER GMBH; vor dem weissen stein 14; albstadt 72461 ; GM 72461
• Manufacturer (Section G): ALBER GMBH; vor dem weissen stein 14; albstadt, baden-württemberg 72461 ; GM 72461
• Manufacturer Contact: christoph hauschel ; vor dem weissen stein 14; albstadt, baden-württemberg 72461 ; GM 72461
• MDR Report Key: 15915382
• MDR Text Key: 304830210
• Report Number: 3004730072-2022-00007
• Device Sequence Number: 1
• Product Code: ING
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K920105
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 11/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: S38
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/11/2022
• Initial Date FDA Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/23/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization