THOPAZ+ PUMP SALE 0791000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-09-03 for THOPAZ+ PUMP SALE 0791000 manufactured by Medela Ag.

MAUDE Entry Details

Report Number1419937-2019-00115
MDR Report Key8956464
Report SourceHEALTH PROFESSIONAL
Date Received2019-09-03
Date Mfgr Received2019-05-23
Device Manufacturer Date2017-04-13
Date Added to Maude2019-09-03
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 ContactJAN KLOIBER
Manufacturer Street1101 CORPORATE DRIVE
Manufacturer CityMCHENRY IL 60050
Manufacturer CountryUS
Manufacturer Postal60050
Manufacturer Phone8004358316
Manufacturer G1MEDELA AG
Manufacturer StreetLATTICHSTRASSE 4B
Manufacturer CityBAAR 6341,
Manufacturer CountrySZ
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTHOPAZ+ PUMP SALE
Generic NamePUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)
Product CodeBTA
Date Received2019-09-03
Returned To Mfg2019-05-24
Model Number0791000
Catalog Number0791000
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMEDELA AG
Manufacturer AddressLATTICHSTRASSE 4B BAAR 6341, SZ


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-09-03

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