PUREWICK FEMALE EXTERNAL PWF030

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor,other report with the FDA on 2019-12-27 for PUREWICK FEMALE EXTERNAL PWF030 manufactured by Adaptec Medical Devices Llc 3014271001.

Event Text Entries

[172825857] The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10


[172825858] It was reported that the wicks do not suction and have caused the customer an uti. It is unknown what medical interventions were given for the uti.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018233-2019-08256
MDR Report Key9523228
Report SourceCONSUMER,DISTRIBUTOR,OTHER
Date Received2019-12-27
Date of Report2020-02-21
Date Mfgr Received2020-02-10
Date Added to Maude2019-12-27
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 ContactYONIC ANDERSON
Manufacturer Street8195 INDUSTRIAL BLVD
Manufacturer CityCOVINGTON GA 30014
Manufacturer CountryUS
Manufacturer Postal30014
Manufacturer Phone7707846100
Manufacturer G1ADAPTEC MEDICAL DEVICES LLC 3014271001
Manufacturer Street260 JAMES JACKSON AVENUE
Manufacturer CityCARY NC 27513
Manufacturer CountryUS
Manufacturer Postal Code27513
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePUREWICK FEMALE EXTERNAL
Generic NameWICK
Product CodeNZU
Date Received2019-12-27
Catalog NumberPWF030
Lot NumberUNK
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerADAPTEC MEDICAL DEVICES LLC 3014271001
Manufacturer Address260 JAMES JACKSON AVENUE CARY NC 27513 US 27513


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-12-27

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