PLACKERS PKFL TWN LN MNT 150

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-25 for PLACKERS PKFL TWN LN MNT 150 manufactured by Ranir Llc.

Event Text Entries

[138090766] Consumer stated he/she had been a long time user of plackers twin line flossers she recently purchased a new pack at (b)(6) and immediately noticed that the plastic material used is different. "it? S stiff and less pliable and when flip down the toothpick it often breaks off as the material doesn't bend well. Right off i noticed hearing/feeling a? Snap? Like breaking noise on the first bend? Then after 2 or 3 bends it often breaks off on one or both sides? This is not something i experienced in prior years of using and can say it almost never became detached. "
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1825660-2019-00508
MDR Report Key8368329
Date Received2019-02-25
Date of Report2019-02-25
Date of Event2019-01-30
Date Facility Aware2019-01-30
Date Mfgr Received2019-01-30
Date Added to Maude2019-02-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactREBEKAH STENSKE
Manufacturer Street4701 EAST PARIS AVE. SE
Manufacturer CityGRAND RAPIDS MI 495125353
Manufacturer CountryUS
Manufacturer Postal495125353
Manufacturer Phone6166988880
Manufacturer G1RANIR LLC
Manufacturer Street4701 EAST PARIS AVE. SE
Manufacturer CityGRAND RAPIDS MI 495125353
Manufacturer CountryUS
Manufacturer Postal Code495125353
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NamePLACKERS
Generic NameFLOSS, DENTAL
Product CodeJES
Date Received2019-02-25
Returned To Mfg2019-02-11
Model NumberPKFL TWN LN MNT 150
Lot Number8197A
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerRANIR LLC
Manufacturer Address4701 EAST PARIS AVE. SE GRAND RAPIDS MI 495125353 US 495125353


Patients

Patient NumberTreatmentOutcomeDate
10 2019-02-25

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