BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9995015 · Received April 24, 2020

    Report

    Report Number
    2951250-2020-05445
    Event Type
    Injury
    Date Received
    April 24, 2020
    Date of Event
    September 1, 2016
    Report Date
    May 6, 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 AN ADULT 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. IN (B)(6) 2016, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("BLOATING LOOKED LIKE I WAS 8 MONTHS PREGNANT") AND SYSTEMIC LUPUS ERYTHEMATOSUS ("LUPUS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (OVARIES WERE NOT REMOVED)). ESSURE WAS REMOVED IN (B)(6) 2016. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL, ABDOMINAL DISTENSION AND SYSTEMIC LUPUS ERYTHEMATOSUS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, MEDICAL DEVICE REMOVAL AND SYSTEMIC LUPUS ERYTHEMATOSUS TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT HAD BLOATING AND LOOKED LIKE SHE WAS PREGNANT FOR 8 MONTHS. SHE HAD CHECKED HER THYROID AND THEY WERE STILL CHECKING HER FOR LUPUS. BECAUSE ONE OF THE LUPUS CAME BACK ABNORMAL. HAD SURGERY IN (B)(6). DEVICE WAS REMOVED AT AGE OF 35. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WERE REPORTED VIA SOCIAL MEDIA: MEDICAL DEVICE REMOVAL. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 30-APR-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.

    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 AN ADULT 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. IN SEPTEMBER 2016, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("BLOATING LOOKED LIKE I WAS 8 MONTHS PREGNANT") AND SYSTEMIC LUPUS ERYTHEMATOSUS ("LUPUS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (OVARIES WERE NOT REMOVED)). ESSURE WAS REMOVED IN (B)(6) 2016. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL, ABDOMINAL DISTENSION AND SYSTEMIC LUPUS ERYTHEMATOSUS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, MEDICAL DEVICE REMOVAL AND SYSTEMIC LUPUS ERYTHEMATOSUS TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT HAD BLOATING AND LOOKED LIKE SHE WAS PREGNANT FOR 8 MONTHS. SHE HAD CHECKED HER THYROID AND THEY WERE STILL CHECKING HER FOR LUPUS. BECAUSE ONE OF THE LUPUS CAME BACK ABNORMAL. HAD SURGERY IN (B)(6). DEVICE WAS REMOVED AT AGE OF (B)(6). CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WERE REPORTED VIA SOCIAL MEDIA: MEDICAL DEVICE REMOVAL. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-MAR-2020: FU 1, 2 AND 3 WERE PROCESSED TOGETHER. SOCIAL MEDIA RECEIVED: EVENT MEDICAL DEVICE REMOVAL AND REPORTER INFORMATION WERE ADDED. ON 23-MAR-2020: FU 1, 2 AND 3 WERE PROCESSED TOGETHER. NO NEW CLINICAL INFORMATION WAS ADDED. ON 23-MAR-2020: FU 1, 2 AND 3 WERE PROCESSED TOGETHER. CONTENT FROM SOCIAL MEDIA RECEIVED. AGE GROUP OF PATIENT WAS ADDED. REPORTER 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
    458765 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R