BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALL-FLEX ARCING DIAPHRAGM (SILICONE)

    MDR report key: 3393594 · Received August 23, 2013

    Report

    Report Number
    2242843-2013-00671
    Event Type
    Malfunction
    Date Received
    August 23, 2013
    Date of Event
    November 1, 2012
    Report Date
    November 20, 2012
    Manufacturer
    JOHNSON & JOHNSON MEDICAL BRAZIL (JJMB)
    Product Code
    HDW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO EVENT REPORTED WITH THIS PRODUCT QUALITY COMPLAINT FOR DEFECT IN DIAPHRAGM. THE PATIENT HAD NOT RECOVERED FROM DEFECT IN DIAPHRAGM. THIS REPORT IS ASSOCIATED WITH (B)(4). THIS REPORT WAS SERIOUS (REPORTABLE MALFUNCTION).

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED FROM A PHARMACIST CONCERNING A FEMALE PATIENT (AGE UNSPECIFIED) FROM THE UNITED STATES WITH LOCAL CASE ID: (B)(6). THE PATIENT'S WEIGHT, HEIGHT AND MEDICAL HISTORY WERE NOT REPORTED. THE PATIENT WAS TREATED WITH THE ALL-FLEX ARCING SPRING DIAPHRAGM (SILICONE) (HDW - CONTRACEPTIVE DIAPHRAGM AND ACCESSORIES), 75 MM, (LOT B33EU1, EXPIRATION OCT-2015), (B)(4), ONE DIAPHRAGM AS NEEDED/INTRAVAGINAL FOR BIRTH CONTROL. CONCOMITANT MEDICATIONS WERE NOT REPORTED. A PHARMACIST REPORTED THAT A PATIENT PICKED UP HER PRESCRIPTION FOR THE ALL-FLEX ARCING SPRING DIAPHRAGM (SILICONE) ON (B)(6) 2012. ON AN UNSPECIFIED DATE, THE PATIENT REQUESTED A REPLACEMENT FOR THE DIAPHRAGM BECAUSE OF DEFECTS. THE PHARMACIST ASKED THE PATIENT WHAT SHE MEANT BY "DEFECTS" AND THE PATIENT REPLIED THAT THERE WAS "A SMALL SECTION OF THE DIAPHRAGM THAT HAD A LITTLE INDENTATION OR CUT/DENT IN IT" (REPORTED AS DEFECT IN DIAPHRAGM), (DEVICE MALFUNCTION). THE PATIENT RETURNED THE DIAPHRAGM TO THE PHARMACY ON AN UNSPECIFIED DATE. IT WAS NOTED THAT THE PHARMACIST DID NOT HAVE ANOTHER REPLACEMENT DIAPHRAGM TO GIVE TO THE PATIENT AND THEREFORE THE PATIENT WAS WITHOUT A DIAPHRAGM AT THE TIME OF REPORTING. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412982 ALL-FLEX ARCING DIAPHRAGM (SILICONE) HDW JOHNSON & JOHNSON MEDICAL BRAZIL (JJMB) UNK B33EU1

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other