PUREWICK FEMALE EXTERNAL CATHETER PWF030

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-12 for PUREWICK FEMALE EXTERNAL CATHETER PWF030 manufactured by Purewick Corporation ? 3012224959.

Event Text Entries

[100148339] The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10


[100148340] It was initially reported that the patient experienced perineal bleeding as a result of the suction on the purewick being too high. Per additional information received, the patient did not experience perineal bleeding but redness around the area. No medical intervention was required. The complainant reported that the pressure was set at 160mm.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018233-2018-00429
MDR Report Key7264793
Date Received2018-02-12
Date of Report2018-03-01
Date Mfgr Received2018-02-20
Date Added to Maude2018-02-12
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 ContactAMY GRAVLEY
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 Report0

Device Details

Brand NamePUREWICK FEMALE EXTERNAL CATHETER
Generic NamePUREWICK
Product CodeNNW
Date Received2018-02-12
Catalog NumberPWF030
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
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
10 2018-02-12

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