U BY KOTEX UNKNOWN : TAMPON, MENSTRUAL, UNSCENTED : HEB

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 2020-03-30 for U BY KOTEX UNKNOWN : TAMPON, MENSTRUAL, UNSCENTED : HEB manufactured by Kimberly-clark Corporation.

MAUDE Entry Details

Report Number3003701733-2020-00171
MDR Report Key9897925
Report SourceCONSUMER
Date Received2020-03-30
Date of Report2020-03-30
Date of Event2020-03-17
Date Mfgr Received2020-03-17
Date Added to Maude2020-03-30
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 ContactMRS. EMILY ARNOULD, RN BSN
Manufacturer Street2100 WINCHESTER RD
Manufacturer CityNEENAH WI 54956
Manufacturer CountryUS
Manufacturer Postal54956
Manufacturer Phone9207213128
Manufacturer G1KIMBERLY-CLARK CORPORATION
Manufacturer Street2100 WINCHESTER RD.
Manufacturer CityNEENAH WI 54956
Manufacturer CountryUS
Manufacturer Postal Code54956
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameU BY KOTEX UNKNOWN : TAMPON, MENSTRUAL, UNSCENTED : HEB
Generic NameTAMPON, MENSTRUAL, UNSCENTED
Product CodeHEB
Date Received2020-03-30
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerKIMBERLY-CLARK CORPORATION
Manufacturer Address2100 WINCHESTER RD. NEENAH WI 54956 US 54956


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-30

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