BEUDAMED
    FDA Adverse Event Injury Summary report: N

    K-Y BRAND PRODUCTS

    MDR report key: 3161396 · Received June 11, 2013

    Report

    Report Number
    2214133-2013-00045
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    May 13, 2013
    Manufacturer
    SKILLMAN CONTRACT
    Product Code
    KMJ
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013, FROM A MALE CONSUMER (AGE UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. THE MEDICAL HISTORY AND THE CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING (B)(4) UNSPECIFIED, TOPICALLY FOR LUBRICATION (LOT NUMBER, EXPIRATION DATE, DOSE AND FREQUENCY UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, HE EXPERIENCED IRRITATION. AFTER AN UNSPECIFIED DURATION, HE AGAIN USED THE SAME DEVICE AND EXPERIENCED IRRITATION, REDNESS, BURNING SENSATION AND DRYNESS ON GENITAL AREA. HE DEVELOPED A CHEMICAL BURN AND HIS SKIN CAME OFF. HE ALSO STATED THAT HIS TONGUE SKIN TORE OFF AND THROAT SWELLED UP. HE STATED THAT THE PACKAGE DID NOT CONTAIN WARNING LABEL THAT THE DEVICE MIGHT CAUSE CHEMICAL BURN OR SKIN TO COME OFF. THE ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. THE EVENTS DID NOT RESOLVE. CONSUMER DID NOT REPORT A SPECIFIC PRODUCT NAME OR LOT NUMBER. A REVIEW OF THE TRENDING DATA FOR COMPLAINT REVEALED AN INCREASE IN COMPLAINT VOLUME. SINCE SPECIFIC PRODUCT NAMES WERE NOT REPORTED, IT WAS NOT POSSIBLE TO DETERMINE WHICH (B)(4) PRODUCT HAD CONTRIBUTED TO THE INCREASE IN COMPLAINT VOLUME. COMPLAINT TREND MONITORING WOULD CONTINUE. THIS REPORT WAS ASSESSED AS SERIOUS (MEDICALLY SIGNIFICANT). THE COMPANY CAUSALITY WAS ASSESSED AS POSSIBLE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013. BASED ON THE INFORMATION AVAILABLE, THE DEVICE WAS USED AS INTENDED FOR TREATMENT. NO FURTHER INVESTIGATION REQUIRED. NO ADVERSE TRENDS WERE IDENTIFIED DURING THE COMPLAINT INVESTIGATION. COMPLAINT TRENDS WOULD CONTINUE TO BE MONITORED. THIS REPORT REMAINS SERIOUS.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013, FROM A MALE CONSUMER (AGE UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. THE MEDICAL HISTORY AND THE CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING K-Y UNSPECIFIED, TOPICALLY FOR LUBRICATION (LOT NUMBER, EXPIRATION DATE, DOSE AND FREQUENCY UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, HE EXPERIENCED IRRITATION. AFTER AN UNSPECIFIED DURATION, HE AGAIN USED THE SAME DEVICE AND EXPERIENCED IRRITATION, REDNESS, BURNING SENSATION AND DRYNESS ON GENITAL AREA. HE DEVELOPED A CHEMICAL BURN AND HIS SKIN CAME OFF. HE ALSO STATED THAT HIS TONGUE SKIN TORE OFF AND THROAT SWELLED UP. HE STATED THAT THE PACKAGE DID NOT CONTAIN WARNING LABEL THAT THE DEVICE MIGHT CAUSE CHEMICAL BURN OR SKIN TO COME OFF. THE ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. THE EVENTS DID NOT RESOLVE. CONSUMER DID NOT REPORT A SPECIFIC PRODUCT NAME OR LOT NUMBER. A REVIEW OF THE TRENDING DATA FOR COMPLAINT REVEALED AN INCREASE IN COMPLAINT VOLUME. SINCE SPECIFIC PRODUCT NAMES WERE NOT REPORTED, IT WAS NOT POSSIBLE TO DETERMINE WHICH K-Y PRODUCT HAD CONTRIBUTED TO THE INCREASE IN COMPLAINT VOLUME. COMPLAINT TREND MONITORING WOULD CONTINUE. THIS REPORT WAS ASSESSED AS SERIOUS (MEDICALLY SIGNIFICANT). THE COMPANY CAUSALITY WAS ASSESSED AS POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262451 K-Y BRAND PRODUCTS PERSONAL LUBRICANT KMJ SKILLMAN CONTRACT KYGENRUS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other