BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROJAN PLEASURE PACK LUBRICATED CONDOMS

    MDR report key: 4210777 · Received October 29, 2014

    Report

    Report Number
    2280705-2014-00040
    Event Type
    Injury
    Date Received
    October 29, 2014
    Report Date
    January 29, 2015
    Manufacturer
    CHURCH & DWIGHT CO., INC.
    Product Code
    HIS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HER PLEASURE (SENSATIONS) LOT CODE: TT4192UZ1321. INTENSE CONDOMS LOT CODE: TT4169UZ915. WARMING CONDOMS LOT CODE: TT4172UZ1303. TWISTED CONDOMS LOT CODE: TT4136EZ1309. CARTON LOT CODE: TT4136E. DEVICE MANUFACTURE DATES FOR ABOVE LOT CODES ARE THE FOLLOWING: HER PLEASURE (SENSATIONS) CONDOMS: 07/11/2014. INTENSE CONDOMS: 06/18/2014. WARMING CONDOMS: 06/21/2014. TWISTED CONDOMS: 05/16/2014. CARTON: 05/16/2014.

    Additional Manufacturer Narrative · 1

    510(K) NUMBER FOR TWISTED CONDOMS IS K993735. 510(K) NUMBER FOR SENSATIONS CONDOMS IS K912901. 510(K) NUMBER FOR INTENSE CONDOMS IS K912901. 510(K) NUMBERS FOR WARMING CONDOMS ARE K120249 AND K912901.

    Description of Event or Problem · 1

    CONSUMER REPORTS CONDOM BREAKAGE. CONSUMER REQUIRED INTERVENTION TO PREVENT PERMANENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693775 TROJAN PLEASURE PACK LUBRICATED CONDOMS CONDOM HIS CHURCH & DWIGHT CO., INC. 2260095338

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention