MAUDE Adverse Event Report: ALBER GMBH SCALAMOBIL S30 IQ

Model Number S30

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 03/16/2022

Event Type  Injury  

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.

Event Description

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.

• Brand Name: SCALAMOBIL S30 IQ
• Type of Device: SCALAMOBIL S30 IQ
• 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, germany 72461 ; GM 72461
• Manufacturer Contact: christoph hauschel ; vor dem weissen stein 14; albstadt, baden-württemberg, germany 72461 ; GM 72461
• MDR Report Key: 14520636
• MDR Text Key: 292790071
• Report Number: 3004730072-2022-00003
• 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: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: S30
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2007
• 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