BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9663831 · Received February 4, 2020

    Report

    Report Number
    2951250-2020-00772
    Event Type
    Injury
    Date Received
    February 4, 2020
    Report Date
    May 5, 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 PELVIC PAIN ('PAIN') IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), POST-TRAUMATIC NECK SYNDROME ("WHIPLASH IN MY NECK"), FATIGUE ("FATIGUE") AND IMMUNE SYSTEM DISORDER ("IMMUNE ISSUES"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, POST-TRAUMATIC NECK SYNDROME, FATIGUE AND IMMUNE SYSTEM DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED FATIGUE, IMMUNE SYSTEM DISORDER, PELVIC PAIN AND POST-TRAUMATIC NECK SYNDROME TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS DESCRIBED IN PATIENT¿S SOCIAL MEDIA: MEDICAL DEVICE REMOVAL. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-MAR-2020: SOCIAL MEDIA CONTENT RECEIVED: REPORTER ADDED. EVENT WHIPLASH IN MY NECK WAS ADDED. ON 20-MAR-2020: SOCIAL MEDIA CONTENT RECEIVED: REPORTER ADDED. ON 20-MAR-2020: SOCIAL MEDIA CONTENT RECEIVED: REPORTER ADDED. EVENTS: IMMUNE ISSUES, FATIGUE, PAIN WERE ADDED. ON 20-MAR-2020: SOCIAL MEDIA CONTENT RECEIVED: REPORTER ADDED. FU 1, 2, 3 AND 4 PROCESSED TOGETHER. ON 20-MAR-2020: SOCIAL MEDIA CONTENT RECEIVED: 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.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN') IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), POST-TRAUMATIC NECK SYNDROME ("WHIPLASH IN MY NECK"), FATIGUE ("FATIGUE"), IMMUNE SYSTEM DISORDER ("IMMUNE ISSUES") AND ACNE ("ACNE"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, POST-TRAUMATIC NECK SYNDROME, FATIGUE, IMMUNE SYSTEM DISORDER AND ACNE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ACNE, FATIGUE, IMMUNE SYSTEM DISORDER, PELVIC PAIN AND POST-TRAUMATIC NECK SYNDROME TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: NEVER HAD ACNE BEFORE ESSURE. MY DERMATOLOGIST SAID IT WAS HORMONE-RELATED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS DESCRIBED IN PATIENT¿S SOCIAL MEDIA: 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 CONTENT RECEIVED: NEW EVENT "ACNE" 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.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN') IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), POST-TRAUMATIC NECK SYNDROME ("WHIPLASH IN MY NECK"), FATIGUE ("FATIGUE"), IMMUNE SYSTEM DISORDER ("IMMUNE ISSUES") AND ACNE ("ACNE"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, POST-TRAUMATIC NECK SYNDROME, FATIGUE, IMMUNE SYSTEM DISORDER AND ACNE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ACNE, FATIGUE, IMMUNE SYSTEM DISORDER, PELVIC PAIN AND POST-TRAUMATIC NECK SYNDROME TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: NEVER HAD ACNE BEFORE ESSURE. MY DERMATOLOGIST SAID IT WAS HORMONE-RELATED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS DESCRIBED IN PATIENT¿S SOCIAL MEDIA: MEDICAL DEVICE REMOVAL. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-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 ('3 WEEKS POST OPERATIVE') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. 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 (ESSURE REMOVAL). ESSURE WAS REMOVED. 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 WAS DESCRIBED IN PATIENT¿S SOCIAL MEDIA: MEDICAL DEVICE REMOVAL. 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
    128659 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other| R