BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9539136 · Received January 2, 2020

    Report

    Report Number
    2951250-2020-00009
    Event Type
    Injury
    Date Received
    January 2, 2020
    Report Date
    January 9, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('MEDICAL DEVICE REMOVAL') AND AUTOIMMUNE DISORDER ('AUTOIMMUNE ISSUES') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND EXPERIENCED AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (SURGERY TO REMOVE ESSURE). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL AND AUTOIMMUNE DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED AUTOIMMUNE DISORDER AND MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED BY VIA SOCIAL MEDIA: MEDICAL DEVICE REMOVAL. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINTS. AMENDMENT: THE REPORT WAS AMENDED FOR THE FOLLOWING REASON: THIS CASE WAS FOUND TO BE DUPLICATE OF CASE 2017-219436, THEREFORE THE CASE WAS MARKED FOR DELETION. LEGACY DEVICE REPORT NUM 2951250-2020-00009 (FROM DELETED CASE (B)(4)). LEGACY DEVICE REPORT NUM 2951250-2017-07703 (FROM RETAINED CASE (B)(4)). NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('MEDICAL DEVICE REMOVAL') AND AUTOIMMUNE DISORDER ('AUTOIMMUNE ISSUES') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND EXPERIENCED AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (SURGERY TO REMOVE ESSURE). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL AND AUTOIMMUNE DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED AUTOIMMUNE DISORDER AND MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED BY VIA SOCIAL MEDIA: MEDICAL DEVICE REMOVAL . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINTS. NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1068 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R