SCALACOMBI S36

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-05-17 for SCALACOMBI S36 manufactured by Alber Gmbh.

Event Text Entries

[75344623] Device returned to manufacturer, no malfunction found.
Patient Sequence No: 1, Text Type: N, H10


[75344664] While the wife was using the scalacombi s36 to transport her husband down the stairs, the device allegedly tilted sideways to the wall causing her husband to hit his head. The husband was admitted to the hospital for head injury and lacerations. The event occurred in (b)(6).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004730072-2017-00001
MDR Report Key6572329
Report SourceCONSUMER
Date Received2017-05-17
Date of Report2017-05-17
Date of Event2017-04-13
Date Mfgr Received2017-04-18
Device Manufacturer Date2014-06-27
Date Added to Maude2017-05-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationMEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR JASON FIEST
Manufacturer StreetONE INVACARE WAY
Manufacturer CityELYRIA OH 44036
Manufacturer CountryUS
Manufacturer Postal44036
Manufacturer Phone8003336900
Manufacturer G1ALBER GMBH
Manufacturer CountryGM
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSCALACOMBI S36
Generic NameELEVATOR
Product CodeING
Date Received2017-05-17
Model NumberS36
OperatorMEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerALBER GMBH
Manufacturer AddressVOR DEM WEISSEN STEIN 21, ALBSTADT, GERMANY 72461 GM 72461


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2017-05-17

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