APDP BASE BP EN ES USA 101035078

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 2019-11-19 for APDP BASE BP EN ES USA 101035078 manufactured by Medela Llc.

MAUDE Entry Details

Report Number1419937-2019-00149
MDR Report Key9341513
Report SourceCONSUMER
Date Received2019-11-19
Date of Event2019-10-25
Date Mfgr Received2019-10-25
Device Manufacturer Date2018-10-31
Date Added to Maude2019-11-19
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 LLC
Manufacturer Street1101 CORPORATE DR
Manufacturer CityMCHENRY IL 60050
Manufacturer CountryUS
Manufacturer Postal Code60050
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAPDP BASE BP EN ES USA
Generic NamePUMP, BREAST, POWERED
Product CodeHGX
Date Received2019-11-19
Returned To Mfg2019-11-11
Model Number101035078
Catalog Number101035078
Lot Number449352
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMEDELA LLC
Manufacturer Address1101 CORPORATE DR MCHENRY IL 60050 US 60050


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-11-19

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