GENERAL PURPOSE PROBE COVER GPC396EU

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-11-22 for GENERAL PURPOSE PROBE COVER GPC396EU manufactured by Ecolab/microtek Medical.

MAUDE Entry Details

Report Number8043817-2019-40035
MDR Report Key9365898
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-11-22
Date of Report2019-11-22
Date of Event2019-10-23
Date Mfgr Received2019-10-23
Device Manufacturer Date2019-05-26
Date Added to Maude2019-11-22
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 ContactANULI OKOLO-YOUNG
Manufacturer Street1 ECOLAB PLACE
Manufacturer CityST PAUL MN 55102
Manufacturer CountryUS
Manufacturer Postal55102
Manufacturer Phone6512502237
Manufacturer G1MICROTEK DOMINICANA, S.A.
Manufacturer StreetLAS AMERICAS FREE ZONE PARK KM 22
Manufacturer CitySANTO DOMINGO, 11606
Manufacturer CountryDR
Manufacturer Postal Code11606
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGENERAL PURPOSE PROBE COVER
Generic NameGENERAL PROBE COVER
Product CodeKKX
Date Received2019-11-22
Model NumberGPC396EU
Lot NumberD191261
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerECOLAB/MICROTEK MEDICAL
Manufacturer Address1 ECOLAB PLACE ST PAUL MN 55102 US 55102


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-22

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