BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6820156 · Received August 25, 2017

    Report

    Report Number
    2951250-2017-03183
    Event Type
    Injury
    Date Received
    August 25, 2017
    Report Date
    August 25, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY AN OTHER HEALTH PROFESSIONAL AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ("THE DOCTOR ATTEMPTED TO REMOVE HER ESSURE ABOUT A YEAR OR TWO AGO, AND IT BROKE AND FRAGMENTED") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. 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 EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND COMPLICATION OF DEVICE REMOVAL ("THE DOCTOR ATTEMPTED TO REMOVE HER ESSURE ABOUT A YEAR OR TWO AGO, AND IT BROKE AND FRAGMENTED"). THE PATIENT WAS TREATED WITH SURGERY. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE AND COMPLICATION OF DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED COMPLICATION OF DEVICE REMOVAL AND DEVICE BREAKAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: IT WAS REPORTED THAT SHE JUST DOES IMAGING, AND ESSURE REMOVED BUT THERE ARE STILL FRAGMENTS OF THE PRODUCT INSIDE THE PATIENT. COMPANY CAUSALITY COMMENT: 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
    601659 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R