BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10002928 · Received April 27, 2020

    Report

    Report Number
    2951250-2020-05750
    Event Type
    Injury
    Date Received
    April 27, 2020
    Report Date
    April 27, 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

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('JUST 1 WEEK POST OP') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: SHE HAD NO PAIN, UTI (URINARY TRACT INFECTION). 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 BLADDER DISCOMFORT ("BLADDER IS FULL CONSTANTLY"), FEELING ABNORMAL ("FEELING CRAZY AND SCATTER BRAINED/FELT LIKE INTERNAL VIBRATIONS"), ANXIETY ("ANXIOUS") AND IMMUNE SYSTEM DISORDER ("MY IMMUNE SYSTEM GOING HAYWIRE"). THE PATIENT WAS TREATED WITH SURGERY (MEDICAL DEVICE REMOVAL). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL, BLADDER DISCOMFORT, FEELING ABNORMAL, ANXIETY AND IMMUNE SYSTEM DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, BLADDER DISCOMFORT, FEELING ABNORMAL, IMMUNE SYSTEM DISORDER AND MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE HAS CONSTANT STATE OF FULLNESS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-MAR-2020: SOCIAL MEDIA RECEIVED: NEW EVENTS FEELING ABNORMAL, ANXIOUS AND IMMUNE SYSTEM DISORDER WERE ADDED. REPORTER ADDED. ON 23-MAR-2020: SOCIAL MEDIA RECEIVED. THE CASE WAS UPGRADED FROM NON-SERIOUS INCIDENT SERIOUS INCIDENT. REMOVAL (MEDICAL DEVICE REMOVAL SURGERY) WAS ADDED. REPORTER WAS ADDED. ON 23-MAR-2020: INFORMATION RECEIVED VIA SOCIAL MEDIA. NO NEW CLINICAL INFORMATION RECEIVED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466438 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R