BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3890148 · Received June 12, 2014

    Report

    Report Number
    2951250-2014-00224
    Event Type
    Injury
    Date Received
    June 12, 2014
    Report Date
    January 19, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PTC INVESTIGATION RESULT WAS RECEIVED ON (B)(4) 2014. THIS ADVERSE EVENT REPORT IS RELATED TO A PRODUCT TECHNICAL COMPLAINT (PTC). (B)(4). FINAL ASSESSMENT: SINCE NO PRODUCT WAS RETURNED TO US FOR INVESTIGATION, WE WERE UNABLE TO PERFORM AN INVESTIGATION OF THE ACTUAL DEVICE INVOLVED IN THIS COMPLAINT. TYPICALLY, WE WOULD INSPECT THE MICRO-INSERT TO CONFIRM THAT ALL PARTS ARE ACCOUNTED FOR AND INSPECT THE DEVICE TO LOOK FOR ANY MANUFACTURING DEFICIENCIES. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT AT THIS TIME. MEDICAL ASSESSMENT: THE REPORTED MEDICAL EVENT IS A POSSIBLE UNDESIRABLE EVENT WITH THE USE OF ESSURE AND IS NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT. NO COMPLAINT SAMPLE WAS PROVIDED FOR A TECHNICAL INVESTIGATION. NO BATCH NUMBER WAS REPORTED. NEITHER A TECHNICAL BATCH INVESTIGATION NOR A BATCH CLUSTER REVIEW IN THE (B)(4) DATABASE FOR A MORE DETAILED STATISTICAL MEDICAL EVALUATION IS POSSIBLE WITHOUT A BATCH NUMBER. AT THE TIME OF THIS MEDICAL ASSESSMENT THE TECHNICAL INVESTIGATION CONCLUDED "UNCONFIRMED QUALITY DEFECT". BASED ON THE INFORMATION AVAILABLE, THERE IS NO REASON TO SUSPECT A QUALITY DEFECT.

    Additional Manufacturer Narrative · 1

    DATA CORRECTION FOR US REPORTING: THE CODE KNH WAS REPLACED WITH HHS.

    Description of Event or Problem · 1

    THIS CASE REPORT FROM UNITED STATES WAS DERIVED FROM MEDICAL LITERATURE ON 14-MAY-2014, ARTICLE ENTITLED "SUBSEROSAL MISPLACEMENT OF ESSURE DEVICE MANIFESTED BY LATE-ONSET ACUTE PELVIC PAIN". IT REFERS TO A FEMALE PATIENT OF UNSPECIFIED AGE WHO REC'D FALLOPIAN TUBE OCCLUSION INSERT (FALLOPIAN TUBE OCCLUSION INSERT) FOR HYSTEROSCOPIC STERILIZATION AND EXPERIENCED PAIN STARTED IMMEDIATELY AFTER THE ESSURE PLACEMENT. CASE REPORT: THIS CASE REFERS TO A PATIENT WHO EXPERIENCED PERSISTENT ABDOMINAL PAIN 2 WEEKS AFTER ESSURE PLACEMENT LASTING FOR MORE THAN 6 WEEKS. NO APPARENT PELVIC PATHOLOGIC CONDITION WAS DIAGNOSED, AND THE PAIN WAS GONE AFTER ESSURE DEVICE REMOVAL. RELATED CASE FROM THE SAME ARTICLE: (B)(4). COMPANY CAUSALITY COMMENT: A CASE OF PAIN STARTED 2 WEEKS AFTER THE ESSURE PLACEMENT IN A FEMALE PATIENT OF UNSPECIFIED AGE IN ASSOCIATION OF ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) WAS DERIVED FROM THE MEDICAL LITERATURE. ESSURE WAS REMOVED APPROXIMATELY TWO MONTHS AFTER INSERTION. PAIN STARTED 2 WEEKS AFTER THE ESSURE PLACEMENT WAS REGARDED SERIOUS (INTERVENTION PERFORMED FOR ESSURE REMOVAL) AND LISTED FOR ESSURE IN THE REFERENCE SAFETY INFO. GIVEN THE COMPATIBLE TEMPORAL RELATIONSHIP AND THE LACK OF AN ALTERNATIVE EXPLANATION PAIN STARTED 2 WEEKS AFTER THE ESSURE PLACEMENT WAS REGARDED RELATED TO ESSURE USE AND AS AN INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347756 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 Other