FREESTYLE BREAST PUMP - SINGLE 101034712

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-11-15 for FREESTYLE BREAST PUMP - SINGLE 101034712 manufactured by Medela Ag.

MAUDE Entry Details

Report Number1419937-2019-00148
MDR Report Key9329696
Report SourceCONSUMER
Date Received2019-11-15
Date of Event2019-10-18
Date Mfgr Received2019-10-23
Date Added to Maude2019-11-15
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 ZUG 6341
Manufacturer CountrySZ
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFREESTYLE BREAST PUMP - SINGLE
Generic NamePUMP, BREAST, POWERED
Product CodeHGX
Date Received2019-11-15
Model Number101034712
Catalog Number101034712
Lot NumberNI
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMEDELA AG
Manufacturer AddressLATTICHSTRASSE 4B BAAR ZUG 6341, SZ


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-11-15

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