PUREWICK FEMALE EXTERNAL DD15

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2019-07-10 for PUREWICK FEMALE EXTERNAL DD15 manufactured by Purewick Corporation ? 3012224959.

MAUDE Entry Details

Report Number1018233-2019-03787
MDR Report Key8775999
Report SourceCONSUMER,OTHER
Date Received2019-07-10
Date of Report2019-08-08
Date Mfgr Received2019-07-24
Date Added to Maude2019-07-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactYONIC ANDERSON
Manufacturer Street8195 INDUSTRIAL BLVD
Manufacturer CityCOVINGTON GA 30014
Manufacturer CountryUS
Manufacturer Postal30014
Manufacturer Phone7707846100
Manufacturer G1PUREWICK CORPORATION
Manufacturer Street203 GILLESPIE WAY
Manufacturer CityEL CAJON CA 92020
Manufacturer CountryUS
Manufacturer Postal Code92020
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePUREWICK FEMALE EXTERNAL
Generic NamePUREWICK DRYDOC STATION
Product CodeNZU
Date Received2019-07-10
Catalog NumberDD15
Lot NumberNA
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerPUREWICK CORPORATION ? 3012224959
Manufacturer Address203 GILLESPIE WAY EL CAJON CA 92020 US 92020


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-07-10

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