KY LIQUIBEADS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-16 for KY LIQUIBEADS manufactured by .

Event Text Entries

[71202173] The k-y beads did not work. My gyn suggested these for chronic vaginal dryness. One of the six in the package with applicator worked. The second package, none worked. I recall checking the k-y beads out online afterwards and read where they had been recalled previously and wondered if correct information was on the internet. One of the twelve beads worked. Package had six and an applicator. I tried a second package, and none worked. The six pack with the applicator averages/estimated price is around (b)(4) and more. One of the twelve tablets worked. Date the person first started taking or using the product: (b)(6) 2017. Date the person stopped taking or using the product: (b)(6) 2017. Did the problem stop after person reduced the dose or stopped taking or using the product: no, defective.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5068701
MDR Report Key6439210
Date Received2017-03-16
Date of Report2017-03-10
Date of Event2017-02-15
Date Added to Maude2017-03-28
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameKY LIQUIBEADS
Generic NameKY LIQUIBEADS
Product CodeNUC
Date Received2017-03-16
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2017-03-16

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