BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10736428 · Received October 26, 2020

    Report

    Report Number
    2951250-2020-15398
    Event Type
    Injury
    Date Received
    October 26, 2020
    Report Date
    October 30, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE EXPULSION ('WAS FOUND IN THE UTERUS NEAR THE FUNDUS/MALPOSITION OF ESSURE RIGHT SIDE') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), DYSMENORRHOEA ("DYSMENORRHEA"), DYSPAREUNIA ("DYSPAREUNIA"), FATIGUE ("FATIGUE"), MOOD ALTERED ("BAD MOOD"), MIGRAINE ("MIGRAINES"), NAUSEA ("NAUSEA"), PELVIC PAIN ("PELVIC PAIN"), ABDOMINAL PAIN UPPER ("STOMACH PAIN"), BACK PAIN ("BACK PAIN"), RIGHT LOWER QUADRANT PAIN ("LOWER BELLY RIGHT LOWER QUADRANT PAIN"), LEFT LOWER QUADRANT PAIN ("LOWER BELLY LEFT LOWER QUADRANT PAIN"), MENTAL DISORDER ("PSYCHOLOGICAL PROBLEMS"), STRESS ("STRESS"), ANXIETY ("ANXIETY"), ERYTHEMA ("RED SPOT IN BOTH LEGS"), CYST ("CYST IN RIGHT SIDE"), ABDOMINAL DISTENSION ("BLOATING") AND ANAEMIA ("ANEMIA") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL) AND SALPINGECTOMY BILATERAL). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, VAGINAL HAEMORRHAGE, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, MOOD ALTERED, MIGRAINE, NAUSEA, PELVIC PAIN, ABDOMINAL PAIN UPPER, BACK PAIN, RIGHT LOWER QUADRANT PAIN, LEFT LOWER QUADRANT PAIN, MENTAL DISORDER, STRESS, ANXIETY, ERYTHEMA, CYST, WEIGHT INCREASED, ABDOMINAL DISTENSION AND ANAEMIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN UPPER, ANAEMIA, ANXIETY, BACK PAIN, CYST, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, ERYTHEMA, FATIGUE, MENTAL DISORDER, MIGRAINE, MOOD ALTERED, NAUSEA, PELVIC PAIN, RIGHT LOWER QUADRANT PAIN, STRESS, VAGINAL HAEMORRHAGE, WEIGHT INCREASED AND LEFT LOWER QUADRANT PAIN TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. AMENDMENT: THE REPORT WAS AMENDED FOR THE FOLLOWING REASON: THIS CASE WAS FOUND TO BE DUPLICATE OF CASE (B)(4), ALL INFORMATION FROM THIS CASE WERE TRANSFERRED TO CASE (B)(4). NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION 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 DEVICE EXPULSION ('WAS FOUND IN THE UTERUS NEAR THE FUNDUS/MALPOSITION OF ESSURE RIGHT SIDE') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), DYSMENORRHOEA ("DYSMENORRHEA"), DYSPAREUNIA ("DYSPAREUNIA"), FATIGUE ("FATIGUE"), MOOD ALTERED ("BAD MOOD"), MIGRAINE ("MIGRAINES"), NAUSEA ("NAUSEA"), PELVIC PAIN ("PELVIC PAIN"), ABDOMINAL PAIN UPPER ("STOMACH PAIN"), BACK PAIN ("BACK PAIN"), RIGHT LOWER QUADRANT PAIN ("LOWER BELLY RIGHT LOWER QUADRANT PAIN"), LEFT LOWER QUADRANT PAIN ("LOWER BELLY LEFT LOWER QUADRANT PAIN"), MENTAL DISORDER ("PSYCHOLOGICAL PROBLEMS"), STRESS ("STRESS"), ANXIETY ("ANXIETY"), ERYTHEMA ("RED SPOT IN BOTH LEGS"), CYST ("CYST IN RIGHT SIDE"), ABDOMINAL DISTENSION ("BLOATING") AND ANAEMIA ("ANEMIA") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL) AND SALPINGECTOMY BILATERAL). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, VAGINAL HAEMORRHAGE, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, MOOD ALTERED, MIGRAINE, NAUSEA, PELVIC PAIN, ABDOMINAL PAIN UPPER, BACK PAIN, RIGHT LOWER QUADRANT PAIN, LEFT LOWER QUADRANT PAIN, MENTAL DISORDER, STRESS, ANXIETY, ERYTHEMA, CYST, WEIGHT INCREASED, ABDOMINAL DISTENSION AND ANAEMIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN UPPER, ANAEMIA, ANXIETY, BACK PAIN, CYST, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, ERYTHEMA, FATIGUE, MENTAL DISORDER, MIGRAINE, MOOD ALTERED, NAUSEA, PELVIC PAIN, RIGHT LOWER QUADRANT PAIN, STRESS, VAGINAL HAEMORRHAGE, WEIGHT INCREASED AND LEFT LOWER QUADRANT PAIN TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS 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
    1199156 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R