L.TAMPONSORGCOTTON

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 2020-03-19 for L.TAMPONSORGCOTTON manufactured by Ontex Hygieneartikel Gmbh.

MAUDE Entry Details

Report Number9615100-2020-00002
MDR Report Key9853579
Report SourceCONSUMER
Date Received2020-03-19
Date of Report2020-02-18
Date Mfgr Received2020-02-18
Date Added to Maude2020-03-19
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 ContactMGR. REGULATORY FEMININE CARE
Manufacturer StreetWINTON HILL BUSINESS CENTER B6280 CENTER HILL AVENUE
Manufacturer CityCINCINNATI, OH
Manufacturer CountryUS
Manufacturer G1ONTEX HYGIENEARTIKEL GMBH
Manufacturer CityGROSSPOSTWITZ, SACHSEN
Manufacturer CountryGM
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameL.TAMPONSORGCOTTON
Generic NameTAMPON, MENSTRUAL, UNSCENTED
Product CodeHEB
Date Received2020-03-19
Lot NumberNOT AVAILABLE
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerONTEX HYGIENEARTIKEL GMBH
Manufacturer AddressGROSSPOSTWITZ, SACHSEN GM


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-19

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