BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADIANA PERMANENT CONTRACEPTION SYSTEM

    MDR report key: 2253972 · Received September 14, 2011

    Report

    Report Number
    1222780-2011-00170
    Event Type
    Injury
    Date Received
    September 14, 2011
    Report Date
    August 17, 2011
    Manufacturer
    HOLOGIC
    Product Code
    KNH
    PMA / PMN Number
    P070022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT AND SERIAL NUMBERS OF THE DISPOSABLE DEVICES NOT PROVIDED BY THE COMPLAINANT, THEREFORE THE EXPIRATION DATES ARE NOT KNOWN. SERIAL NUMBER OF THE RADIO FREQUENCY GENERATOR NOT PROVIDED BY THE COMPLAINANT. (B)(4) PREGNANCY POST PERMANENT CONTRACEPTION PROCEDURE. THE DEVICES ARE NOT BEING RETURNED THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICES CANNOT BE COMPLETED. LOT NUMBERS OF THE DISPOSABLE DEVICES NOT PROVIDED BY THE COMPLAINANT, THEREFORE THE MANUFACTURE DATE IS NOT KNOWN. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE CONDUCTED FOR THE DISPOSABLE DEVICES AS THE LOT AND SERIAL NUMBERS WERE NOT PROVIDED BY THE COMPLAINANT. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) BOXED WARNING: THE ADIANA METHOD SHOULD NOT BE RELIED ON FOR CONTRACEPTION UNTIL THE PT HAS UNDERGONE HYSTEROSALPINGOGRAPHY (HSG) 3 MONTHS AFTER THE ADINA RF TREATMENT/MATRIX PLACEMENT PROCEDURE. THE THREE-MONTH HSG MUST DEMONSTRATE BILATERAL TUBAL OCCLUSION BEFORE THE PT MAY RELY ON ADIANA PERMANENT CONTRACEPTION FOR PREGNANCY PREVENTION. (B)(4).

    Description of Event or Problem · 1

    A PT WAS DIAGNOSED WITH AN INTRAUTERINE PREGNANCY (DATE UNK) POST ADIANA PROCEDURE FOR PERMANENT CONTRACEPTION (DATE UNK). NO HYSTEROSALPINGOGRAPHY WAS SCHEDULED OR DONE. THE PT WAS DIAGNOSED AT BIRTH WITH COARCTATION OF THE AORTA. AT THIS TIME THE AORTA IS "SCLEROSING AND SHE WAS SCHEDULED FOR THE AORTA TO BE REOPENED." THIS SURGERY IS NOW ON HOLD. WE HAVE BEEN UNABLE TO OBTAIN ADD'L INFO SURROUNDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADIANA PERMANENT CONTRACEPTION SYSTEM KNH HOLOGIC NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other RADIO FREQUENCY GENERATOR - SERIAL NUMBER UNK