BEUDAMED
    FDA Adverse Event Summary report: N

    ESSURE

    MDR report key: 3884543 · Received June 13, 2014

    Report

    Report Number
    2951250-2014-00226
    Date Received
    June 13, 2014
    Date of Event
    May 8, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    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 MEDICAL DOCTOR IN UNITED STATES ON (B)(6) 2014 WHICH REFERS TO A FEMALE PATIENT OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED BILATERAL SALPINGECTOMY. NO INFORMATION GIVEN ON PATIENT MEDICAL HISTORY, PAST DRUGS, CONCURRENT CONDITIONS AND CONCOMITANT MEDICATION. ON AN UNSPECIFIED DATE THE PATIENT HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERTS) INSERTED FOR PERMANENT BIRTH CONTROL. REPORTER DID NOT INFORM ITS LOT NUMBER AND EXPIRATION DATE. NURSE REPORTED THAT ON (B)(6) 2014, THE PHYSICIAN DID A BILATERAL SALPINGECTOMY ON A PATIENT WHO HAD ESSURE PLACED. NO ADDITIONAL INFORMATION WAS PROVIDED. REPORTER CAUSALITY: THE RELATIONSHIP BETWEEN THE EVENT AND ESSURE WAS NOT REPORTED. RESULT AND ASSESSMENT OF THE PRODUCT TECHNICAL COMPLAINT INVESTIGATION RECEIVED ON (B)(6) 2014: 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. NO CAPA INVESTIGATION IS REQUIRED AT THIS TIME PER CRITERIA ESTABLISHED IN (B)(4), "PROCESSING ESSURE CASES IN (B)(4)." MEDICAL ASSESSMENT: THE MEDICAL EVENT REPORTED 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 GPV DATABASE FOR A MORE 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. THE PTC GLOBAL NUMBER IS (B)(4). FOLLOW-UP RECEIVED ON (B)(6) 2014: THE REQUIRED NUMBER OF FOLLOW-UP ATTEMPTS HAVE BEEN MADE, WITH NO RESPONSE TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351337 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 Other