BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 5170869 · Received October 23, 2015

    Report

    Report Number
    2951250-2015-01213
    Event Type
    Injury
    Date Received
    October 23, 2015
    Report Date
    January 20, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A CONSUMER IN THE UNITED STATES ON 24-SEP-2015 WHICH REFERS TO ANOTHER FEMALE CONSUMER OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED. THE CONSUMER REPORTED HER SISTER HAD ESSURE AND HAD TO HAVE A TUBAL. CASE CONSIDERED POTENTIAL LEGAL CASE SINCE REPORTER STATED SHE MIGHT CONTACT A LAWYER. PRODUCT TECHNICAL COMPLAINT (PTC) INVESTIGATION AND FINAL ASSESSMENT WERE RECEIVED ON 09-OCT-2015. THE BAYER REFERENCE NUMBER FOR THE PTC REPORT IS: (B)(4). FINAL ASSESSMENT FOR CASES WHERE A DEVICE FAILURE DURING INSERTION IS REPORTED, WE CONDUCT AN INVESTIGATION OF ANY RETURNED DEVICE. FOR CASES WHERE AN INSERT IS REMOVED AT A LATER TIME AFTER INSERTION, WE TYPICALLY DO NOT CONDUCT AN INSPECTION OF THE INSERT. IN THIS CASE, NO PRODUCT WAS RETURNED. 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 OR DEVICE MALFUNCTION AT THIS TIME. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. MEDICAL ASSESSMENT NO PRODUCT QUALITY DEFECT WAS CONFIRMED THEREFORE A RELATIONSHIP TO THE REPORTED MEDICAL EVENT(S) IS EXCLUDED. THE TECHNICAL ASSESSMENT CONCLUDED UNCONFIRMED QUALITY DEFECT. BASED ON THE AVAILABLE INFORMATION, THERE IS NO RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENT(S) AND A QUALITY DEFECT. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND HAD TO HAVE A TUBAL (TUBAL LIGATION). CONSUMER MIGHT CONTACT A LAWYER (POTENTIAL LEGAL CASE). THE REPORTED EVENT WAS CONSIDERED SERIOUS, DUE TO MEDICAL IMPORTANCE AND IS LISTED ACCORDING TO THE REFERENCE SAFETY INFORMATION FOR ESSURE. IN THIS PARTICULAR CASE, LIMITED INFORMATION WAS PROVIDED. SINCE THE EXACT REASON FOR THE PROCEDURE WAS NOT SPECIFIED AND IT WAS UNKNOWN WHETHER SERIOUS INJURY OCCURRED, A CAUSAL RELATIONSHIP BETWEEN THE REPORTED EVENT AND ESSURE THERAPY CANNOT BE EXCLUDED AND DUE TO THE SURGICAL INTERVENTION, THIS CASE WAS CONSIDERED AN INCIDENT. SINCE NO PRODUCT WAS PROVIDED AND NO BATCH NUMBER WAS PROVIDED A QUALITY DEFECT CANNOT BE CONFIRMED. BASED ON AVAILABLE INFORMATION, THERE IS NO REASON TO SUSPECT THAT THE EVENTS WERE CAUSED BY A POTENTIAL QUALITY DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702158 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R