BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10507019 · Received September 9, 2020

    Report

    Report Number
    2951250-2020-14049
    Event Type
    Injury
    Date Received
    September 9, 2020
    Report Date
    September 28, 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 DEVICE DISLOCATION ('MIGRATION') AND EMBEDDED DEVICE ('EMBEDDED METAL COILS ARE NOTED WITHIN EACH CORNU') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. 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 DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("WORSENING PAIN") AND GENITAL HAEMORRHAGE ("WORSENING ABNORMAL BLEEDING"). THE PATIENT WAS TREATED WITH SURGERY (SHE HAD UNDERGONE ESSURE REMOVAL SURGERY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, EMBEDDED DEVICE, PELVIC PAIN AND GENITAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE DISLOCATION, EMBEDDED DEVICE, GENITAL HAEMORRHAGE 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 DEVICE DISLOCATION ('MIGRATION') AND EMBEDDED DEVICE ('EMBEDDED METAL COILS ARE NOTED WITHIN EACH CORNU') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. 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 DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("WORSENING PAIN") AND GENITAL HAEMORRHAGE ("WORSENING ABNORMAL BLEEDING"). THE PATIENT WAS TREATED WITH SURGERY (SHE HAD UNDERGONE ESSURE REMOVAL SURGERY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, EMBEDDED DEVICE, PELVIC PAIN AND GENITAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE DISLOCATION, EMBEDDED DEVICE, GENITAL HAEMORRHAGE 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
    976494 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R