DEPEND UNDERGARMENTS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ EXTRA LARGE FOR WOMEN, MAXIMUM 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 2019-08-06 for DEPEND UNDERGARMENTS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ EXTRA LARGE FOR WOMEN, MAXIMUM ABSORBENCY manufactured by Neenah Cold Spring Facility.

MAUDE Entry Details

Report Number2184163-2019-00003
MDR Report Key8866046
Report SourceCONSUMER
Date Received2019-08-06
Date of Report2019-08-06
Date of Event2019-06-23
Date Mfgr Received2019-07-16
Date Added to Maude2019-08-06
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 G1NEENAH COLD SPRING FACILITY
Manufacturer Street1050 COLD SPRING ROAD
Manufacturer CityNEENAH WI 54956
Manufacturer CountryUS
Manufacturer Postal Code54956
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 Received2019-08-06
Model NumberEXTRA LARGE FOR WOMEN, MAXIMUM ABSORBENCY
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerNEENAH COLD SPRING FACILITY
Manufacturer Address1050 COLD SPRING ROAD NEENAH WI 54956 US 54956


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Life Threatening 2019-08-06

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