SCALAMOBIL S39 EU:1521110

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-10-23 for SCALAMOBIL S39 EU:1521110 manufactured by Alber Gmbh.

MAUDE Entry Details

Report Number3004730072-2019-00008
MDR Report Key9222702
Report SourceOTHER
Date Received2019-10-23
Date of Report2019-09-25
Date of Event2019-09-06
Date Mfgr Received2019-09-25
Device Manufacturer Date2018-04-13
Date Added to Maude2019-10-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. CHRISTOPH HAUSCHEL
Manufacturer StreetVOR DEM WEISSEN STEIN 21
Manufacturer CityALBSTADT, BADEN-W 72461
Manufacturer CountryGM
Manufacturer Postal72461
Manufacturer G1ALBER GMBH
Manufacturer StreetVOR DEM WEISSEN STEIN 21
Manufacturer CityALBSTADT, BADEN-W 72461
Manufacturer CountryGM
Manufacturer Postal Code72461
Single Use3
Remedial ActionIN
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSCALAMOBIL S39
Generic NameSCALAMOBIL
Product CodeING
Date Received2019-10-23
Returned To Mfg2019-10-04
Model NumberEU:1521110
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerALBER GMBH
Manufacturer AddressVOR DEM WEISSEN STEIN 21 ALBSTADT, BADEN-W?RTTEMBERG, GERMANY 72461 GM 72461


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2019-10-23

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