REACH J&J DENTOTAPE RIBBON 381370092216

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 2019-02-22 for REACH J&J DENTOTAPE RIBBON 381370092216 manufactured by Johnson & Johnson Consumer Inc.

Event Text Entries

[136876741] Device was used for treatment, not diagnosis. Age, weight, ethnicity and race was not provided for reporting. This report is for unknown reach j&j dentotape ribbon. Upc#, lot# and udi # is not available. Device is not expected to be returned for manufacturer review/investigation. Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer. Device history records review could not be completed without lot number. (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10


[136876742] A female consumer reported that the reach j&j dentotape ribbon removed part of her tooth while flossing due to the thickness of the product. The consumer sought treatment with her dentist and is scheduled in (b)(6) 2019 to have the tooth repaired. There is no additional information has been provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8041101-2019-00035
MDR Report Key8362035
Report SourceCONSUMER
Date Received2019-02-22
Date of Report2019-04-24
Date Mfgr Received2019-04-24
Device Manufacturer Date2018-05-10
Date Added to Maude2019-02-22
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 ContactLINDA PLEWS
Manufacturer Street199 GRANDVIEW RD
Manufacturer CitySKILLMAN NJ 085589418
Manufacturer CountryUS
Manufacturer Postal085589418
Manufacturer Phone2152737120
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 DENTOTAPE RIBBON
Generic NameDENTAL FLOSS
Product CodeJES
Date Received2019-02-22
Model Number381370092216
Lot Number1308D
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 2019-02-22

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.