REACH J&J FLOSS WAXED 381370092131

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 2019-10-25 for REACH J&J FLOSS WAXED 381370092131 manufactured by Johnson & Johnson Consumer Inc.

MAUDE Entry Details

Report Number8041101-2019-00053
MDR Report Key9238798
Report SourceCONSUMER
Date Received2019-10-25
Date of Report2019-11-11
Date Mfgr Received2019-11-11
Device Manufacturer Date2018-06-06
Date Added to Maude2019-10-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactLAURIE RAUCO
Manufacturer Street199 GRANDVIEW RD
Manufacturer CitySKILLMAN NJ 085589418
Manufacturer CountryUS
Manufacturer Postal085589418
Manufacturer Phone2152734905
Manufacturer G1JOHNSON & JOHNSON CONSUMER PRODUCTS DR PARQUE INDU
Manufacturer StreetPARQUE INDUSTRIAL DE ITABO CARRETERA S
Manufacturer CityHAINA 91000
Manufacturer CountryDR
Manufacturer Postal Code91000
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameREACH J&J FLOSS WAXED
Generic NameDENTAL FLOSS
Product CodeJES
Date Received2019-10-25
Model Number381370092131
Lot Number1528D
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerJOHNSON & JOHNSON CONSUMER INC
Manufacturer Address199 GRANDVIEW RD SKILLMAN NJ 085589418 US 085589418


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-10-25

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