BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 16399011 · Received February 17, 2023

    Report

    Report Number
    2951250-2023-00547
    Event Type
    Injury
    Date Received
    February 17, 2023
    Report Date
    February 17, 2023
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE LONG PELVIC PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE FAILURE, DEFECT ("FAILURE DEFECT (INCL OTHER ORGAN DAMAGE)"). THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. IN (B)(6) 2004, THE PATIENT HAD ESSURE (ESS205) INSERTED. AN UNKNOWN TIME LATER SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), INJURY ("FAILURE DEFECT (INCL OTHER ORGAN DAMAGE)"), SEXUAL DYSFUNCTION ("SEVERE LONG SEXUAL DYSFUNCTION") AND MENTAL DISORDER ("UNSPECIFIED PSYCH INJURY"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (LAPAROSCOPIC)). ESSURE (ESS205) WAS REMOVED. THE REPORTER CONSIDERED INJURY, MENTAL DISORDER, PELVIC PAIN AND SEXUAL DYSFUNCTION TO BE RELATED TO ESSURE (ESS205) ADMINISTRATION. THE REPORTER COMMENTED: INTENTION TO REMOVE THE ESSURE DEVICE. ON (B)(6) 2023 ESSURE REMOVAL WAS REPORTED. ALSO STATED THAT ESSURE HAD IMPACT ON LIFESTYLE. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE (ESS205): UNABLE TO CONFIRM COMPLAINT. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 01-FEB-2023: THE CORRECT IRD IS (B)(6) 2023. AS REPORTED EVENTS PELVIC PAIN AND SEXUAL DISFUNCTION UPDATED, ADDED UNSPECIFIED PSYCH INJURY. ESSURE REMOVAL SURGERY REPORTED SO CASE WAS UPGRADED TO SERIOUS INCIDENT. 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
    126330 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS205 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention