YOURS AND MINE KY

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-18 for YOURS AND MINE KY manufactured by .

Event Text Entries

[38863126] Ky vaginal products appears to have caused burns and blisters for women using the product "yours and mine," and possibly others. I noticed (b)(6) four women complained that the product resulted in burning, and two said the product gave them internal blisters. One woman though it was from menthol in the product. I thought the fda might be interested.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5060423
MDR Report Key5455015
Date Received2016-02-18
Date of Report2016-02-18
Date of Event2016-02-18
Date Added to Maude2016-02-23
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameYOURS AND MINE KY
Generic NameYOURS AND MINE KY
Product CodeNUC
Date Received2016-02-18
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No0
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2016-02-18

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