U BY KOTEX SECURITY : TAMPON, MENSTRUAL, UNSCENTED : HEB SUPER PLUS

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 2020-03-23 for U BY KOTEX SECURITY : TAMPON, MENSTRUAL, UNSCENTED : HEB SUPER PLUS manufactured by Kimberly-clark Corporation - Conway Mill.

Event Text Entries

[184467185] Review of the device history record (dhr) and supporting quality records confirmed no anomalies that may have caused or contributed to the malfunction.
Patient Sequence No: 1, Text Type: N, H10


[184467186] Consumer reported after wearing a tampon for two hours, upon removal the tampon fell apart leaving pieces inside. She was able to manually remove the remaining tampon pieces and did not seek medical attention.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2381757-2020-00337
MDR Report Key9865414
Report SourceCONSUMER
Date Received2020-03-23
Date of Report2020-03-23
Date of Event2020-03-10
Date Mfgr Received2020-03-03
Device Manufacturer Date2019-08-19
Date Added to Maude2020-03-23
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 - CONWAY MILL
Manufacturer Street480 EXCHANGE AVE.
Manufacturer CityCONWAY AR 720327191
Manufacturer CountryUS
Manufacturer Postal Code720327191
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameU BY KOTEX SECURITY : TAMPON, MENSTRUAL, UNSCENTED : HEB
Generic NameTAMPON, MENSTRUAL, UNSCENTED
Product CodeHEB
Date Received2020-03-23
Model NumberSUPER PLUS
Lot NumberAC923122X0112
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerKIMBERLY-CLARK CORPORATION - CONWAY MILL
Manufacturer Address480 EXCHANGE AVE. CONWAY AR 720327191 US 720327191


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-23

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