PNSA STARTER BP EN ES USA 101035077/8107176

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 2020-02-12 for PNSA STARTER BP EN ES USA 101035077/8107176 manufactured by Medela Llc.

MAUDE Entry Details

Report Number1419937-2020-00009
MDR Report Key9700180
Report SourceCONSUMER
Date Received2020-02-12
Date of Event2020-01-21
Date Mfgr Received2020-01-30
Device Manufacturer Date2019-10-03
Date Added to Maude2020-02-12
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
Manufacturer CountryUS
Manufacturer Phone4358316
Manufacturer G1MEDELA LLC
Manufacturer Street1101 CORPORATE DR
Manufacturer CityMCHENRY, IL
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePNSA STARTER BP EN ES USA
Generic NamePUMP, BREAST, POWERED
Product CodeHGX
Date Received2020-02-12
Returned To Mfg2020-02-07
Model Number101035077/8107176
Catalog Number101035077/8107176
Lot Number457007
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMEDELA LLC
Manufacturer Address1101 CORPORATE DR MCHENRY, IL US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-02-12

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