BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7636834 · Received June 26, 2018

    Report

    Report Number
    2951250-2018-02793
    Event Type
    Injury
    Date Received
    June 26, 2018
    Report Date
    October 31, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    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 LICHEN SCLEROSUS ("AUTOIMMUNE CONDITION: LICHEN SCLEROSUS.") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED LICHEN SCLEROSUS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PAIN OF SKIN. THE PATIENT WAS TREATED WITH STEROID ANTIBACTERIALS AND SURGERY (HYSTERECTOMY). ESSURE WAS REMOVED IN (B)(6) 2015. AT THE TIME OF THE REPORT, THE LICHEN SCLEROSUS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED LICHEN SCLEROSUS TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA: LICHEN SCLEROSUS, PAIN OF SKIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 31-OCT-2018: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. INCIDENT: NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF LICHEN SCLEROSUS ("AUTOIMMUNE CONDITION: LICHEN SCLEROSUS.") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED LICHEN SCLEROSUS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PAIN OF SKIN. THE PATIENT WAS TREATED WITH STEROID ANTIBACTERIALS AND SURGERY (HYSTERECTOMY). ESSURE WAS REMOVED IN (B)(6) 2015. AT THE TIME OF THE REPORT, THE LICHEN SCLEROSUS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED LICHEN SCLEROSUS TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA SOCIAL MEDIA: LICHEN SCLEROSUS, PAIN OF SKIN. INCIDENT: NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480750 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R