KY Warming Jelly 00067981089479Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00067981089479), received between May 8, 2019 and May 8, 2019 — classified as 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CASE REFERENCE NUMBER (B)(6) IS A SPONTANEOUS CASE REPORT SENT BY A CONSUMER WHICH REFERS TO A FEMALE AGE UNKNOWN. IT WAS REPORTED THAT TWO WEEKS AGO ON (B)(6) 2019, A FEMALE PATIENT OF AN UNKNOWN AGE HAD USED K-Y WARMING JELLY, DOSE, FREQUENCY, INDICATION, ROUTE, STOP DATE AND DURATION WERE ALL UNKNOWN. PATIENT STATED THAT THE SHE HAD USED THE PRODUCT NUMEROUS TIMES WITH HER PARTNER IN THE PAST FEW WEEKS. TWO WEEKS AGO ((B)(6) 2019) WHEN SHE HAD USED THE PRODUCT, IT CAUSED A SEVERE REACTION. PATIENT HAS BEEN TO THE DOCTORS TWICE NOW, AND SHE WOULD BE GOING BACK AGAIN THIS WEEK, BECAUSE THE LUBE CAUSED HER TO GET SEVERE BURNS AND GENITAL LACERATIONS THAT WERE BEING TREATED WITH ANTIBIOTICS AND PAIN MEDICATIONS. PATIENT STATED THAT SHE HAD BARELY BEEN ABLE TO WALK DUE TO THE EXTREME PAIN FROM THIS INJURY AND THIS HAD AFFECTED HER ABILITY TO ATTEND HER COLLEGE CLASSES AND OTHER OBLIGATIONS. PATIENT STATED THAT THE INJURY WAS CAUSED FROM THE PRODUCT, WHICH HAD BEEN CONFIRMED BY HER DOCTOR. PATIENT STATED THAT SHE HAD BEEN EXPERIENCING EXTREME PAIN FROM HER INJURY FOR OVER 2 WEEKS NOW (AT THE TIME OF REPORTING). AT THE TIME OF REPORTING ACTION TAKEN WITH THE SUSPECT PRODUCT WAS UNKNOWN

  Patient problems: Ambulation or Postural Difficulties; Burning Sensation; Laceration(s); Pain

  MAUDE report 8591110 ↗