BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALL-FLEX ARCING SPRING DIAPHRAGM (SILICONE)

    MDR report key: 3393610 · Received September 11, 2013

    Report

    Report Number
    2242843-2013-00704
    Event Type
    Malfunction
    Date Received
    September 11, 2013
    Report Date
    September 5, 2013
    Manufacturer
    JOHNSON & JOHNSON MEDICAL BRAZIL (JJMB)
    Product Code
    HDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT AVAILABLE FOR RETRIEVAL, THEREFORE NO LOT NUMBER WAS PROVIDED. THIS REPORT WAS CONSIDERED REPORTABLE AS HOLE IN DIAPHRAM IS MEDICALLY SIGNIFICANT WITH THE POTENTIAL FOR PREGNANCY (MEDICAL INJURY).

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED FROM THE MOTHER OF A PATIENT, REPORTING ON HER DAUGHTER, AND CONCERNS A FEMALE PATIENT OF UNSPECIFIED AGE FROM THE UNITED STATES WITH LOCAL CASE ID (B)(6). THE PATIENT'S HEIGHT, WEIGHT, MEDICAL HISTORY, AND CONCOMITANT MEDICATION WERE NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PATIENT WAS TREATED WITH ALL-FLEX ARCING SPRING DIAPHRAGM (SILICONE) (HDW - CONTRACEPTIVE DIAPHRAGM AND ACCESSORIES), ONE DIAPHRAGM AS NEEDED/INTRAVAGINAL FOR BIRTH CONTROL. NO DATE OF THERAPY, LOT NUMBER OR EXPIRATION DATE WAS PROVIDED. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE MOTHER REPORTED THAT ONE OF HER DAUGHTER'S ALL-FLEX ARCING SPRING DIAPHRAGM (SILICONE) HAD A TEAR IN IT (DEVICE MALFUNCTION). IT WAS NOT SPECIFIED IF THE TEAR WAS IDENTIFIED BEFORE OR AFTER PATIENT DIAPHRAGM USAGE. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT OUTCOME WAS NOT KNOWN TEAR IN DIAPHRAGM. THIS REPORT WAS SERIOUS (MEDICALLY SIGNIFICANT) AND REPORTABLE (DEVICE MALFUNCTION). THIS CASE, FROM THE SAME REPORTER IS LINKED TO (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456591 ALL-FLEX ARCING SPRING DIAPHRAGM (SILICONE) HDW JOHNSON & JOHNSON MEDICAL BRAZIL (JJMB) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other