BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10148195 · Received June 12, 2020

    Report

    Report Number
    2951250-2020-08681
    Event Type
    Injury
    Date Received
    June 12, 2020
    Report Date
    July 8, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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/ MEDICAL DEVICE REMOVAL'). 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) 2004, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("PAIN WHEN MY CYCLE AND FEELS LIKEN CONTRACTION/ MENSTRUAL PAIN"), MENORRHAGIA ("HEAVIEST CYCLE/ FLOW WAS HEAVY"), MENSTRUAL DISORDER ("SEVERAL CLOTS") AND BACK PAIN ("BACK PAIN"). THE PATIENT WAS TREATED WITH SURGERY (SHE HAD ESSURE REMOVAL). AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, DYSMENORRHOEA, MENORRHAGIA, MENSTRUAL DISORDER AND BACK PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED BACK PAIN, DEVICE DISLOCATION, DYSMENORRHOEA, MENORRHAGIA AND MENSTRUAL DISORDER 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 IS RETAIN IS RETAIN CASE AND ALL THE INFORMATION FROM CASE 2019-232059 WAS TRANSFERRED TO CASE NO 2019-229249. REPORTER, EVENTS SEVERAL CLOTS AND BACK PAIN AND REFERENCE WERE ADDED. 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 WILL BE 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'), MENORRHAGIA ('HEAVIEST CYCLE') AND DYSMENORRHOEA ('PAIN WHEN MY CYCLE AND FEELS LIKEN CONTRACTION') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. ON (B)(6) 2004, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DYSMENORRHOEA, MENORRHAGIA AND DEVICE DISLOCATION. AT THE TIME OF THE REPORT, THE DYSMENORRHOEA, MENORRHAGIA AND DEVICE DISLOCATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE DISLOCATION, DYSMENORRHOEA AND MENORRHAGIA TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-JAN-2020: PFS RECEIVED- NEW EVENTS MIGRATION WAS ADDED. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION'), MENORRHAGIA ('HEAVIEST CYCLE') AND DYSMENORRHOEA ('PAIN WHEN MY CYCLE AND FEELS LIKEN CONTRACTION') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. ON (B)(6) 2004, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DYSMENORRHOEA, MENORRHAGIA AND DEVICE DISLOCATION. AT THE TIME OF THE REPORT, THE DYSMENORRHOEA, MENORRHAGIA AND DEVICE DISLOCATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE DISLOCATION, DYSMENORRHOEA AND MENORRHAGIA TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-JAN-2020: PFS RECEIVED- NEW EVENTS MIGRATION WAS ADDED. 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
    613058 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R