BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 5108029 · Received September 28, 2015

    Report

    Report Number
    2951250-2015-01135
    Event Type
    Injury
    Date Received
    September 28, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FOLLOW-UP RECEIVED ON 10-DEC-2015: THE REQUIRED NUMBER OF FOLLOW-UP ATTEMPTS HAVE BEEN COMPLETED, WITH NO RESPONSE TO DATE. COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT REFERS TO AN ADULT FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) SURGICALLY REMOVED BY LAPAROSCOPY DUE TO PELVIC PAIN. THE REPORTED EVENT WAS CONSIDERED SERIOUS DUE TO ITS MEDICAL IMPORTANCE AND IS LISTED ACCORDING TO ESSURE'S REFERENCE SAFETY INFORMATION. ABDOMINAL, PELVIC AND UNCHARACTERIZED PAIN MAY OCCUR WITH ESSURE THERAPY. IN THIS PARTICULAR CASE, LIMITED INFORMATION WAS PROVIDED. NEVERTHELESS, GIVEN EVENT'S NATURE; CAUSALITY CANNOT BE EXCLUDED. THIS CASE WAS CONSIDERED AN INCIDENT, SINCE DEVICE REMOVAL WAS REQUIRED. THE TECHNICAL ASSESSMENT CONCLUDED UNCONFIRMED QUALITY DEFECT. BASED ON THE AVAILABLE INFORMATION, THERE IS NO RELATIONSHIP BETWEEN THE REPORTED ADVERSE EVENT AND A QUALITY DEFECT. FOLLOW-UP INFORMATION COULD NOT BE OBTAINED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A MEDICAL DOCTOR IN UNITED STATES ON 31-AUG-2015. IT REFERS TO AN ADULT FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED FOR PERMANENT CONTRACEPTION ON AN UNSPECIFIED DATE. THE PATIENT WAS NOT PREGNANT. ON (B)(6) 2015 A SURGICAL LAPAROSCOPIC REMOVAL OF ESSURE WAS PERFORMED DUE TO PELVIC PAIN. PTC INVESTIGATION RESULT WAS RECEIVED ON 15-SEP-2015. THIS ADVERSE EVENT REPORT IS RELATED TO A PRODUCT TECHNICAL COMPLAINT (PTC). THE BAYER REFERENCE NUMBER FOR THE PTC REPORT IS: PTC LOCAL NUMBER (B)(4) AND PTC GLOBAL NUMBER (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 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 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 ADVERSE EVENT(S) IS EXCLUDED. THE TECHNICAL ASSESSMENT CONCLUDED UNCONFIRMED QUALITY DEFECT. BASED ON THE AVAILABLE INFORMATION, THERE IS NO RELATIONSHIP BETWEEN THE REPORTED ADVERSE EVENT AND A QUALITY DEFECT. COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT REFERS TO AN ADULT FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) SURGICALLY REMOVED BY LAPAROSCOPY DUE TO PELVIC PAIN. THE REPORTED EVENT WAS CONSIDERED SERIOUS DUE TO ITS MEDICAL IMPORTANCE AND IS LISTED ACCORDING TO ESSURE'S REFERENCE SAFETY INFORMATION. ABDOMINAL, PELVIC AND UNCHARACTERIZED PAIN MAY OCCUR WITH ESSURE THERAPY. IN THIS PARTICULAR CASE, LIMITED INFORMATION WAS PROVIDED. NEVERTHELESS, GIVEN EVENT'S NATURE; CAUSALITY CANNOT BE EXCLUDED. THIS CASE WAS CONSIDERED AN INCIDENT, SINCE DEVICE REMOVAL WAS REQUIRED. THE TECHNICAL ASSESSMENT CONCLUDED UNCONFIRMED QUALITY DEFECT. BASED ON THE AVAILABLE INFORMATION, THERE IS NO RELATIONSHIP BETWEEN THE REPORTED ADVERSE EVENT AND A QUALITY DEFECT. FOLLOW-UP INFORMATION IS BEING SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638677 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R