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KY Touch 2-in-1 Massage Creme & Pleasure Gel Personal LubricantRecalls & reported problems

RB Health (us) LLC · Personal Lubricant · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00067981962161), received between Aug 27, 2018 and Aug 27, 2018 — 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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Dyspnea1
  • Hypersensitivity/Allergic reaction1
  • Rash1

Recent adverse event reports

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

  • InjuryAug 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    EXTREME ALLERGIC REACTION [HYPERSENSITIVITY] PATIENT HAD HARD TIME WITH BREATHING. [DYSPNOEA] SLIGHT SKIN RASH [RASH]. COUGHING [COUGH]. PHLEGM IN LUNGS [PRODUCTIVE COUGH]. CASE DESCRIPTION: INITIAL REPORT, RECEIVED DATE: 14-AUG-2018. RECEIVED FROM CONSUMER RELATIONS, COUNTRY: UNITED STATES, REFERENCE NO: (B)(4). MEDICAL DEVICE: K-Y TOUCH 2 IN 1 MASSAGE CREME AND PLEASURE GEL. CASE REFERENCE NUMBER US-(B)(6) IS A SPONTANEOUS CASE REPORT SENT BY A CONSUMER WHICH REFERS TO A MALE AGE UNKNOWN. IT WAS REPORTED BY PATIENT'S PARTNER THAT ON AN UNKNOWN DATE, THEIR HUSBAND OF AN UNKNOWN AGE USED K-Y TOUCH 2 IN 1 MASSAGE CREME AND PLEASURE GEL FOR AN UNKNOWN INDICATION. REPORTER STATED THAT THEY RECENTLY PURCHASED THE PRODUCT AND ON AN UNKNOWN DATE, PATIENT HAD AN EXTREME ALLERGIC REACTION WITH HARD TIME BREATHING, COUGHING, PHLEGM IN HIS LUNGS AND SLIGHT SKIN RASH AFTER USING THE PRODUCT. THE CASE WAS DEEMED SERIOUS BECAUSE IT WAS CLASSED AS MEDICALLY SIGNIFICANT. FOLLOW UP HAS BEEN REQUESTED TO OBTAIN FURTHER INFORMATION. THE COMPANY'S ASSESSMENT IS SERIOUS WITH A RELATEDNESS OF POSSIBLE AND UNANTICIPATED. CASE OUTCOME: UNKNOWN.

    Patient problems: Dyspnea; Hypersensitivity/Allergic reaction; Rash

    MAUDE report 7820426 ↗

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Sources and updates

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