BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    SKYN ELITE LARGE CONDOM 12CT WM

    MDR report key: 15797217 · Received November 15, 2022

    Report

    Report Number
    3002808272-2022-00000
    Event Type
    Malfunction
    Date Received
    November 15, 2022
    Date of Event
    July 8, 2022
    Report Date
    July 14, 2022
    Manufacturer
    SURETEX LIMITED
    Product Code
    MOL
    UDI-DI
    00070907274125
    PMA / PMN Number
    K171172
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    REFERRED BY THE CONSUMER PRODUCT SAFETY COMMISSION OF THE UNITED STATES OF AMERICA. ON (B)(6) 2022, ME, (B)(6) AND MY WIFE WERE HAVING INTERCOURSE, WHEN THE CONDOM BROKE. THE CONDOM BROKE, AT THE TIP, WHILE EJACULATING, INSIDE OF MY WIFE. BECAUSE THE CONDOM BROKE, WHILE EJACULATING, INSIDE OF MY WIFE, THERE IS A GOOD CHANCE THAT MY WIFE WILL HAVE AN UNPLANNED PREGNANCY. I CONSIDER A PRODUCT THAT BREAKS, SUCH AS CONDOM, TO BE A DEFECTIVE PRODUCT, NO MATTER WHETHER THE DEFECT WAS INTENTIONAL OR NOT. THIS DEFECTIVE CONDOM WAS A LIFESTYLES SKYN, SYNTHETIC POLYISOPRENE CONDOM. THE CONDOM'S PACKAGE STATES DESCRIPTIVE DETAILS SUCH AS ELITE LARGE, ELITE GRAND FORMAT, LOT: 2107733116, EXP: 2026-06-30, NOM: 56MM, MFG/FAB: THAILAND. I WOULD LIKE THIS ORGANIZATION TO SEEK ANY AND ALL REMEDIES POSSIBLE FOR THIS DAMAGED PRODUCT, THAT I RELIED ON, TO PREVENT AN UNPLANNED PREGNANCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103560 SKYN ELITE LARGE CONDOM 12CT WM SKYN ELITE LARGE MOL SURETEX LIMITED 7412 2107733116 00070907274125

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other