BEUDAMED
    FDA Adverse Event Injury Summary report: N

    K-Y BRAND JELLY

    MDR report key: 2525327 · Received April 10, 2012

    Report

    Report Number
    2214133-2012-00002
    Event Type
    Injury
    Date Received
    April 10, 2012
    Report Date
    January 3, 2012
    Manufacturer
    SKILLMAN CONTRACT
    Product Code
    KMJ
    PMA / PMN Number
    K810310
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FOREIGN FOLLOW UP REPORT THAT IS BEING SUBMITTED AS A SERIOUS INJURY FOR A PRODUCT THAT IS SAME/SIMILAR TO A US MARKETED PRODUCT. THE DATE OF THIS SUBMISSION IS (B)(4) 2012. THIS REPORT IS BEING SUBMITTED TO CORRECT THE FOLLOW UP MANUFACTURER REPORT NUMBER PREVIOUSLY SUBMITTED ON (B)(4) 2012, FROM 2214133-2012-00014 TO 2214133-2012-00002. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS IS A FOREIGN REPORT THAT IS BEING SUBMITTED AS A SERIOUS INJURY FOR A PRODUCT THAT IS SAME/SIMILAR TO A US MARKETED PRODUCT. THE DATE OF THIS SUBMISSION IS (B)(6) 2012. THIS REPORT IS BEING SUBMITTED TO CORRECT THE INITIAL MANUFACTURER REPORT NUMBER PREVIOUSLY SUBMITTED ON (B)(6) 2012, FROM 2214133-2012-00014 TO 2214133-2012-00002. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED BY A (B)(6) JOHNSON AFFILIATE ON (B)(6) 2012, FROM A CONSUMER REPORTING ON SELF FROM (B)(6). THE MEDICAL HISTORY INCLUDED AN UNSPECIFIED THYROID PROBLEM FOR AN UNSPECIFIED DURATION AND A HYSTERECTOMY IN 2011. THE CONCOMITANT MEDICATIONS WERE NOT REPORTED ON AN UNSPECIFIED DATE IN 2011, THE CONSUMER STARTED USING AN UNSPECIFIED AMOUNT OF K-Y BRAND JELLY TOPICALLY FOR GENERAL LUBRICATION (LOT NUMBER, FREQUENCY AND EXPIRATION DATE UNSPECIFIED) AFTER HAVING UNDERGONE A HYSTERECTOMY. AFTER AN UNSPECIFIED DURATION, THE CONSUMER DEVELOPED A BLADDER INFECTION AND COULD NOT VOID URINE AND WHEN SHE DID IT WAS BLOOD COLORED. THE CONSUMER WAS HOSPITALIZED FOR AN UNSPECIFIED DURATION. THE MEDICAL TREATMENT GIVEN IN THE HOSPITAL WAS NOT SPECIFIED. THE USE OF THE PRODUCT WAS DISCONTINUED ON AN UNSPECIFIED DATE AND THE OUTCOME OF THE EVENTS WERE RECOVERED. THIS REPORT WAS ASSESSED AS SERIOUS (MEDICALLY SIGNIFICANT). THE COMPANY CAUSALITY WAS ASSESSED AS POSSIBLE.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED BY A (B)(4) JOHNSON & JOHNSON AFFILIATE ON (B)(6) 2012, FROM A CONSUMER REPORTING ON SELF FROM (B)(4). THE MEDICAL HISTORY INCLUDED AN UNSPECIFIED THYROID PROBLEM FOR AN UNSPECIFIED DURATION AND A HYSTERECTOMY IN 2011. THE CONCOMITANT MEDICATIONS WERE NOT REPORTED ON AN UNSPECIFIED DATE IN 2011 THE CONSUMER STARTED USING AN UNSPECIFIED AMOUNT OF K-Y BRAND JELLY TOPICALLY FOR GENERAL LUBRICATION (LOT NUMBER, FREQUENCY AND EXPIRATION DATE UNSPECIFIED) AFTER HAVING UNDERGONE A HYSTERECTOMY. AFTER AN UNSPECIFIED DURATION, THE CONSUMER DEVELOPED A BLADDER INFECTION AND COULD NOT VOID URINE AND WHEN SHE DID IT WAS BLOOD COLORED. THE CONSUMER WAS HOSPITALIZED FOR AN UNSPECIFIED DURATION. THE MEDICAL TREATMENT GIVEN IN THE HOSPITAL WAS NOT SPECIFIED. THE USE OF THE PRODUCT WAS DISCONTINUED ON AN UNSPECIFIED DATE AND THE OUTCOME OF THE EVENTS WERE RECOVERED. THIS REPORT WAS ASSESSED AS SERIOUS (MEDICALLY SIGNIFICANT). THE COMPANY CAUSALITY WAS ASSESSED AS POSSIBLE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2012: THE QUALITY INVESTIGATION WAS CONCLUDED ON (B)(6) 2012, AND NO QUALITY RELATED ISSUES HAVE BEEN IDENTIFIED THAT WOULD WARRANT FURTHER QUALITY INVESTIGATION. THE CUSTOMER DID NOT REPORT A SPECIFIC PRODUCT OR LOT NUMBER FOR INVESTIGATION; THEREFORE LOT TRENDING COULD NOT BE PERFORMED. A REVIEW OF THE COMPLAINT DATA ASSOCIATED WITH THIS COMPLAINT CATEGORY REVEALED THAT THERE IS ONE OTHER ADVERSE EVENT "OTHER" GENITAL/ANAL/REPRODUCTIVE COMPLAINT REPORTED FOR K-Y JELLY. A REVIEW OF THE COMPLAINT DATA ASSOCIATED WITH THIS COMPLAINT CATEGORY DID NOT IDENTIFY ANY RECENT ADVERSE TREND FOR THIS PRODUCT WITHIN THE PAST 24 MONTHS. THIS REPORT REMAINS SERIOUS (MEDICALLY SIGNIFICANT) AND THE COMPANY CAUSALITY WAS ASSESSED AS POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 K-Y BRAND JELLY LUBRICANT, PATIENT KMJ SKILLMAN CONTRACT NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R