DEPEND UNDERGARMENTS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ INCONTINENCE SHIELDS FOR MEN, LIGHT ABSORBENCY

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 2019-06-20 for DEPEND UNDERGARMENTS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ INCONTINENCE SHIELDS FOR MEN, LIGHT ABSORBENCY manufactured by Kimberly-clark Personal Hygienic Products Co. ,ltd.

MAUDE Entry Details

Report Number9615625-2019-00002
MDR Report Key8716135
Report SourceCONSUMER
Date Received2019-06-20
Date of Report2019-06-20
Date of Event2019-03-05
Date Mfgr Received2019-06-01
Device Manufacturer Date2018-08-23
Date Added to Maude2019-06-20
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 ContactMR. CHRIS MAERTZ
Manufacturer Street2100 WINCHESTER RD
Manufacturer CityNEENAH WI 54956
Manufacturer CountryUS
Manufacturer Postal54956
Manufacturer Phone9207214907
Manufacturer G1KIMBERLY-CLARK PERSONAL HYGIENIC PRODUCTS CO. ,LTD
Manufacturer StreetNO. 2 JIAN AN STREET ECONOMIC TECHNOLOGY
Manufacturer CityDEVELOPMENT ZONE, BEIJING 100176
Manufacturer CountryCH
Manufacturer Postal Code100176
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDEPEND UNDERGARMENTS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ
Generic NameGARMENT, PROTECTIVE, FOR INCONTINENCE
Product CodeEYQ
Date Received2019-06-20
Model NumberINCONTINENCE SHIELDS FOR MEN, LIGHT ABSORBENCY
Lot NumberBJ823505X0246
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerKIMBERLY-CLARK PERSONAL HYGIENIC PRODUCTS CO. ,LTD
Manufacturer AddressNO. 2 JIAN AN STREET ECONOMIC TECHNOLOGY DEVELOPMENT ZONE, BEIJING 100176 CH 100176


Patients

Patient NumberTreatmentOutcomeDate
10 2019-06-20

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