THERMOFLATOR 26432020-1

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 2019-11-06 for THERMOFLATOR 26432020-1 manufactured by Karl Storz Se & Co. Kg.

MAUDE Entry Details

Report Number9610617-2019-00105
MDR Report Key9288462
Report SourceOTHER
Date Received2019-11-06
Date of Report2019-11-05
Date of Event2017-10-26
Date Mfgr Received2019-11-05
Date Added to Maude2019-11-06
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 ContactMRS. SUSIE CHEN
Manufacturer Street2151 E. GRAND AVENUE
Manufacturer CityEL SEGUNDO CA 902455017
Manufacturer CountryUS
Manufacturer Postal902455017
Manufacturer Phone4242188201
Manufacturer G1KARL STORZ SE & CO. KG
Manufacturer StreetDR.-KARL-STORZ-STRASSE 34 78532
Manufacturer CityTUTTLINGEN,
Manufacturer CountryGM
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTHERMOFLATOR
Generic NameINSUFFLATOR
Product CodeHIF
Date Received2019-11-06
Model Number26432020-1
Catalog Number26432020-1
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerKARL STORZ SE & CO. KG
Manufacturer AddressDR.-KARL-STORZ-STRASSE 34 78532 TUTTLINGEN, GM


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-11-06

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