BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9976653 · Received April 20, 2020

    Report

    Report Number
    2951250-2020-04578
    Event Type
    Injury
    Date Received
    April 20, 2020
    Report Date
    April 20, 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 ABDOMINAL PAIN ('SORE/ I REALLY THOUGHT I WAS PREGNANT LOL') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL TENDERNESS ("SENSITIVE/ I REALLY THOUGHT I WAS PREGNANT LOL"), ALOPECIA ("LOSING HAIR"), ABDOMINAL DISTENSION ("BLOATING"), DEPRESSION ("DEPRESSION") AND DYSGEUSIA ("TASTE OF METAL IN MY MOUTH"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, ABDOMINAL TENDERNESS, ALOPECIA, ABDOMINAL DISTENSION, DEPRESSION AND DYSGEUSIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL TENDERNESS, ALOPECIA, DEPRESSION AND DYSGEUSIA TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-MAR-2020: SOCIAL MEDIA RECEIVED: EVENT ADDED - LOSING HAIR, BLOATING, DEPRESSION AND TASTE OF METAL IN MY MOUTH. REPORTER INFORMATION ADDED, FU 4, 5, 6 PROCESSED TOGETHER. CASE CATEGORY UPDATED TO SERIOUS INCIDENT, SURGERY DONE. ON 20-MAR-2020: FU 4, 5, 6 PROCESSED TOGETHER. REPORTER ADDED. 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
    441228 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R