LISTERINE SENSITIVITY ZERO ALCOHOL MOUTHRINSE FRESH MINT 312547235976

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 2019-05-28 for LISTERINE SENSITIVITY ZERO ALCOHOL MOUTHRINSE FRESH MINT 312547235976 manufactured by Johnson And Johnson Consumer Inc.

Event Text Entries

[146275518] Device was used for treatment, not diagnosis. Udi# (b)(4). Device is not expected to be returned for manufacturer review/investigation. Concomitant medical products and therapy dates: drug: 100 mg of unknown vitamins & unknown dates. Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer. A review of the device history records has been requested. This is one of two medwatches being submitted as two events were involved with this consumer. See medwatch 2214133-2019-00078 for second occurrence. The same consumer is represented in each medwatch. 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


[146275519] A male consumer reported an event (unknown date) with listerine sensitivity zero alcohol mouthrinse fresh mint. The consumer alleged that his face was swollen after use. The consumer stated he sought medical attention from his health care professional (hcp). The hcp gave the consumer an unknown shot and unknown antibiotic to treat his swollen face. Consumer stated the swelling subsided and went away post treatment. This is one of two medwatches being submitted as two events were involved with this consumer. See medwatch 2214133-2019-00078 for second occurrence. The same consumer is represented in each medwatch.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2214133-2019-00077
MDR Report Key8647236
Report SourceCONSUMER
Date Received2019-05-28
Date of Report2019-05-28
Date Mfgr Received2019-05-28
Device Manufacturer Date2018-03-15
Date Added to Maude2019-05-28
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 G1KIK CUSTOM PRODUCTS - KIK REXDALE
Manufacturer Street2000 KIPLING AVENUE
Manufacturer CityETOBICOKE, ONTARIO M9W 4J6
Manufacturer CountryCA
Manufacturer Postal CodeM9W 4J6
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLISTERINE SENSITIVITY ZERO ALCOHOL MOUTHRINSE FRESH MINT
Generic NameCAVITY VARNISH
Product CodeLBH
Date Received2019-05-28
Model Number312547235976
Lot Number08018CA
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerJOHNSON AND JOHNSON CONSUMER INC
Manufacturer Address199 GRANDVIEW ROAD SKILLMAN NJ 085589418 US 085589418


Patients

Patient NumberTreatmentOutcomeDate
11001. Required No Informationntervention 2019-05-28

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