BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9955912 · Received April 13, 2020

    Report

    Report Number
    2951250-2020-03629
    Event Type
    Injury
    Date Received
    April 13, 2020
    Report Date
    May 26, 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 ('MY E- VICTION DAY') 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 UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND EXPERIENCED MALAISE ("SICK"), APLASTIC ANAEMIA ("APALTIC ANEMIA"), SYSTEMIC LUPUS ERYTHEMATOSUS ("LUPUS") AND AUTOIMMUNE DISORDER ("AUTOIMMUNE DISORDER"). THE PATIENT WAS TREATED WITH SURGERY (SURGERY TO REMOVE ESSURE COILS). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL, MALAISE, APLASTIC ANAEMIA, SYSTEMIC LUPUS ERYTHEMATOSUS AND AUTOIMMUNE DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED APLASTIC ANAEMIA, AUTOIMMUNE DISORDER, MALAISE, MEDICAL DEVICE REMOVAL AND SYSTEMIC LUPUS ERYTHEMATOSUS TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED FROM SOCIAL MEDIA : MEDICAL DEVICE REMOVAL, SICKNESS, LUPUS ERYTHEMATOSIS, APLASTIC ANEMIA QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-MAY-2020: QUALITY SAFETY EVALUATION OF PTC 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.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('MY E- VICTION DAY') 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 UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND EXPERIENCED MALAISE ("SICK"), APLASTIC ANAEMIA ("APALTIC ANEMIA"), SYSTEMIC LUPUS ERYTHEMATOSUS ("LUPUS") AND AUTOIMMUNE DISORDER ("AUTOIMMUNE DISORDER"). THE PATIENT WAS TREATED WITH SURGERY (SURGERY TO REMOVE ESSURE COILS). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL, MALAISE, APLASTIC ANAEMIA, SYSTEMIC LUPUS ERYTHEMATOSUS AND AUTOIMMUNE DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED APLASTIC ANAEMIA, AUTOIMMUNE DISORDER, MALAISE, MEDICAL DEVICE REMOVAL AND SYSTEMIC LUPUS ERYTHEMATOSUS TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED FROM SOCIAL MEDIA : MEDICAL DEVICE REMOVAL, SICKNESS, LUPUS ERYTHEMATOSIS, APLASTIC ANEMIA . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-MAR-2020: SOCIAL MEDIA RECEIVED: EVENTS LUPUS, APLASTIC ANEMIA, SICK WERE ADDED, ON 23-MAR-2020: FU1 AND 2 PROCESSED TOGETHER, ON 23-MAR-2020: SOCIAL MEDIA RECEIVED: NEW REPORTER WERE ADDED, ON 23-MAR-2020: INFORMATION RECEIVED VIA SOCIAL MEDIA: NEW EVENT AUTOIMMUNE DISORDER' ADDED. REPORTER ADDED. 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 ('MY E- VICTION DAY') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. 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). THE PATIENT WAS TREATED WITH SURGERY (SURGERY TO REMOVE ESSURE COILS). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED FROM SOCIAL MEDIA : MEDICAL DEVICE REMOVAL. 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
    419036 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R