BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7073941 · Received December 1, 2017

    Report

    Report Number
    2951250-2017-09515
    Event Type
    Injury
    Date Received
    December 1, 2017
    Report Date
    June 11, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("NEITHER OF MY COILS ARE IN THE MY TUBES. ONE APPEARS TO BE STUCK TO THE MUSCLE AREA OF MY SIDE RIGHT TUBE UNDER MY RIBS THE OTHER IS RIGHT BY MY SPINE HIGHER UP/ NEITHER OF MY COILS ARE IN THE MY TUBES .ONE APPEARS TO BE STUCK TO THE MUSCLE AREA O") AND PELVIC PAIN ("PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ALOPECIA ("HAIR LOSS") AND TOOTH DISORDER ("DENTAL PROBLEMS"). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN, ALOPECIA AND TOOTH DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, DEVICE DISLOCATION, PELVIC PAIN AND TOOTH DISORDER TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE NEITHER OF MY COILS ARE IN THE MY TUBES. ONE APPEARS TO BE STUCK TO THE MUSCLE AREA OF MY SIDE RIGHT TUBE UNDER MY RIBS THE OTHER IS RIGHT BY MY SPINE HIGHER UP WERE REPORTED VIA SOCIAL MEDIA: MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-MAY-2018: CONTENT FROM OTHER REPORTABLE, NEW REPORTER AND EVENT ADDED IN NEITHER OF MY COILS ARE IN THE MY TUBES .ONE APPEARS TO BE STUCK TO THE MUSCLE AREA OF MY SIDE RIGHT TUBE UNDER MY RIBS THE OTHER IS RIGHT BY MY SPINE HIGHER UP. ESSURE LEGAL MANUFACTURE HAS CHANGED FROM BAYER HEALTHCARE, LLC, MILPITAS TO BAYER PHARMA AG, BERLIN, AND THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP TO A PREVIOUS REPORT SUBMITTED UNDER THE FORMER LEGAL MANUFACTURER. REPORT TYPE ¿INITIAL¿ INDICATES HERE INITIAL SUBMISSION BY THE NEW LEGAL MANUFACTURER ONLY. 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 PELVIC PAIN ("PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ALOPECIA ("HAIR LOSS") AND TOOTH DISORDER ("DENTAL PROBLEMS"). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ALOPECIA AND TOOTH DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, PELVIC PAIN AND TOOTH DISORDER TO BE RELATED TO ESSURE. 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
    856074 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R