PATHROMTIN SL 10484200

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-09-06 for PATHROMTIN SL 10484200 manufactured by Siemens Healthcare Diagnostics Products Gmbh.

MAUDE Entry Details

Report Number9610806-2019-00072
MDR Report Key8969327
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2019-09-06
Date of Report2019-09-06
Date of Event2019-08-12
Date Mfgr Received2019-08-12
Date Added to Maude2019-09-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactCHRISTOPHER AEBIG
Manufacturer Street511 BENEDICT AVE
Manufacturer CityTARRYTOWN NY 10591
Manufacturer CountryUS
Manufacturer Postal10591
Manufacturer Phone9145242740
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
Manufacturer StreetEMIL-VON-BEHRING-STR. 76
Manufacturer CityMARBURG, D-35041
Manufacturer CountryGM
Manufacturer Postal CodeD-35041
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePATHROMTIN SL
Generic NamePATHROMTIN SL
Product CodeGFO
Date Received2019-09-06
Model NumberPATHROMTIN SL
Catalog Number10484200
Lot Number536709D
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
Manufacturer AddressEMIL-VON-BEHRING- STR. 76 MARBURG, D-35041 GM D-35041


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-06

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