BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7640794 · Received June 27, 2018

    Report

    Report Number
    2951250-2018-02846
    Event Type
    Injury
    Date Received
    June 27, 2018
    Report Date
    November 1, 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 DEVICE DISLOCATION ("STIMULATOR MIGRATES.") 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 DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND POST PROCEDURAL INFECTION ("POST OP ITS KEEP GETTING INFECTED"). THE PATIENT WAS TREATED WITH SURGERY. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION OUTCOME WAS UNKNOWN AND THE POST PROCEDURAL INFECTION HAD RESOLVED. THE REPORTER CONSIDERED DEVICE DISLOCATION AND POST PROCEDURAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: MY J TUBE IS UNDER CONSTANT SURGEON CARE. AS PER UNDERSTANDING J TUBE IS (G - J TUBE) GASTROSTOMY - JEJUNOSTOMY TUBE. AS PER SOCIAL MEDIA EVENTS ADDED: STIMULATOR MIGRATES AND POST OP ITS KEEP GETTING INFECTED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-NOV-2018: QUALITY-SAFETY EVALUATION OF PTC. 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 DEVICE DISLOCATION ("STIMULATOR MIGRATES") 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 DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND POST PROCEDURAL INFECTION ("POST OP ITS KEEP GETTING INFECTED"). THE PATIENT WAS TREATED WITH SURGERY. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION OUTCOME WAS UNKNOWN AND THE POST PROCEDURAL INFECTION HAD RESOLVED. THE REPORTER CONSIDERED DEVICE DISLOCATION AND POST PROCEDURAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: MY J TUBE IS UNDER CONSTANT SURGEON CARE. AS PER UNDERSTANDING J TUBE IS (G - J TUBE) GASTROSTOMY - JEJUNOSTOMY TUBE. AS PER SOCIAL MEDIA EVENTS ADDED: STIMULATOR MIGRATES AND POST OP ITS KEEP GETTING INFECTED. 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
    482643 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R