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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALBER GMBH SCALAMOBIL S35
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ALBER GMBH SCALAMOBIL S35 Back to Search Results
Model Number S35
Device Problem Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
This event occured in (b)(6).Alber (b)(4) is filing this report because the device is marketed and sold in the u.S.Alber (b)(4) will start the physical evaluation of the device (device returned to alber (b)(4) 23 june 2021).
 
Event Description
It was reported, that the wheel mechanism has become out of sync during use on a stairs climb.The end-user/patient did not fall and was not injured.The device has less than a month of use.
 
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Brand Name
SCALAMOBIL S35
Type of Device
SCALAMOBIL
Manufacturer (Section D)
ALBER GMBH
vor dem weissen stein 14
albstadt, germany 72461
GM  72461
Manufacturer (Section G)
ALBER GMBH
vor de,m weissen stein 14
albstadt, germany 72461
GM   72461
Manufacturer Contact
christoph hauschel
vor dem weissen stein 14
albstadt, germany 72461
GM   72461
MDR Report Key12065277
MDR Text Key258740994
Report Number3004730072-2021-00003
Device Sequence Number1
Product Code ING
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K920105
Number of Events Reported1
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 05/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberS35
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/23/2021
Was the Report Sent to FDA? No
Date Manufacturer Received05/31/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/04/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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