MAUDE Adverse Event Report: ALBER GMBH SCALAMOBIL

Model Number S36

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Event Description

Allegedly on the day of the event, the stairclimber was operated by the life partner.The fall occurred while descending the stairs on the last step.The stairclimber together with the patient had fallen forward one step and the patient suffered a fracture of the neck of the femur.The operator suffered no injuries.The patient is in the hospital for treatment.

Manufacturer Narrative

This event occured in germany.Alber gmbh is filing this report because the device is marketed and sold in the u.S.Alber has requested the involved device for investigation.

• 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 72461 ; GM 72461
• Manufacturer Contact: christoph hauschel ; vor dem weissen stein 14; albstadt 72461 ; GM 72461
• MDR Report Key: 17394880
• MDR Text Key: 319745732
• Report Number: 3004730072-2023-00006
• 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: 07/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: S36
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/04/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/17/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization