BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9686565 · Received February 10, 2020

    Report

    Report Number
    2951250-2020-01159
    Event Type
    Injury
    Date Received
    February 10, 2020
    Report Date
    April 14, 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 MEDICAL DEVICE REMOVAL ('MEDICAL DEVICE REMOVAL') 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 UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND EXPERIENCED SYSTEMIC LUPUS ERYTHEMATOSUS ("LUPUS") AND LIBIDO DECREASED ("SEX DRIVE SKY ROCKETED AFTER REMOVAL"). THE PATIENT WAS TREATED WITH SURGERY (TUVBES AND COILS REMOVED WITH LAP). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL, SYSTEMIC LUPUS ERYTHEMATOSUS AND LIBIDO DECREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED LIBIDO DECREASED, MEDICAL DEVICE REMOVAL AND SYSTEMIC LUPUS ERYTHEMATOSUS TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT AMENDMENT: THE REPORT WAS AMENDED FOR THE FOLLOWING REASON: SOCIAL MEDIA RECEIVED. REPORTER INFORMATION ADDED.THIS CASE MARKED FOR DELETION BECAUSE IT IS FOUND TO BE DUPLICATE OF CASE (B)(4). HENCE ALL THE INFORMATION FROM THIS CASE (B)(4) IS TRANSFERRED INTO RETENTION 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 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 MEDICAL DEVICE REMOVAL ('MEDICAL DEVICE REMOVAL') 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 UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND EXPERIENCED SYSTEMIC LUPUS ERYTHEMATOSUS ("LUPUS") AND LIBIDO DECREASED ("SEX DRIVE SKY ROCKETED AFTER REMOVAL"). THE PATIENT WAS TREATED WITH SURGERY (TUVBES AND COILS REMOVED WITH LAP). AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL, SYSTEMIC LUPUS ERYTHEMATOSUS AND LIBIDO DECREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED LIBIDO DECREASED, MEDICAL DEVICE REMOVAL AND SYSTEMIC LUPUS ERYTHEMATOSUS TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WERE REPORTED VIA SOCIAL MEDIA: SYSTEMIC LUPUS ERYTHEMATOSUS, LIBIDO DECREASED, MEDICAL DEVICE REMOVAL. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: SOCIAL MEDIA RECEIVED. REPORTER INFORMATION ADDED. EVENT: MEDICAL DEVICE REMOVAL , SEX DRIVE SKY ROCKETED WERE ADDED. FU 2 AND 3 PROCESSED TOGETHER. ON (B)(6) 2020: SOCIAL MEDIA RECEIVED. REPORTER INFORMATION ADDED. FU 2 AND 3 PROCESSED TOGETHER. 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
    151340 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R