BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10520216 · Received September 11, 2020

    Report

    Report Number
    2951250-2020-14128
    Event Type
    Injury
    Date Received
    September 11, 2020
    Report Date
    September 24, 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 PELVIC PAIN ('PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. 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 PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MIGRAINE ("MIGRAINE"), HEADACHE ("HEADACHES"), GENITAL HAEMORRHAGE ("ABNORMAL GENITAL BLEEDING"), AUTOIMMUNE DISORDER ("AUTOIMMUNE DISORDER") AND HYPERSENSITIVITY ("HYPERSENSITIVITY SYMPTOM"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MIGRAINE, HEADACHE, GENITAL HAEMORRHAGE, AUTOIMMUNE DISORDER AND HYPERSENSITIVITY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED AUTOIMMUNE DISORDER, GENITAL HAEMORRHAGE, HEADACHE, HYPERSENSITIVITY, MIGRAINE AND PELVIC PAIN TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-SEP-2020: QSE FOR PRODUCT TECHNICAL 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.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. 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 PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MIGRAINE ("MIGRAINE"), HEADACHE ("HEADACHES"), GENITAL HAEMORRHAGE ("ABNORMAL GENITAL BLEEDING"), AUTOIMMUNE DISORDER ("AUTOIMMUNE DISORDER") AND HYPERSENSITIVITY ("HYPERSENSITIVITY SYMPTOM"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MIGRAINE, HEADACHE, GENITAL HAEMORRHAGE, AUTOIMMUNE DISORDER AND HYPERSENSITIVITY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED AUTOIMMUNE DISORDER, GENITAL HAEMORRHAGE, HEADACHE, HYPERSENSITIVITY, MIGRAINE AND PELVIC 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 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
    984778 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R