BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7685431 · Received July 13, 2018

    Report

    Report Number
    2951250-2018-02992
    Event Type
    Injury
    Date Received
    July 13, 2018
    Date of Event
    October 3, 2010
    Report Date
    October 30, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    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 UTERINE PERFORATION ("UTERINE PERFORATION WAS CAUSED BY THE SCOPE") AND GASTROINTESTINAL INJURY ("PERFORATION IN THE BOWEL") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2010, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PROCEDURAL HAEMORRHAGE. ON(B)(6) 2010, THE PATIENT EXPERIENCED GASTROINTESTINAL INJURY (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH INTESTINAL HAEMORRHAGE, THE FIRST EPISODE OF COMPLICATION OF DEVICE INSERTION ("DEVICE INSERTION COMPLICATION") AND THE SECOND EPISODE OF COMPLICATION OF DEVICE INSERTION ("ESSURE INSERTION FAILED"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED BURSITIS ("I HAD BURSITIS") AND ARTHRALGIA ("HIP PAIN"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPY/ HYSTERECTOMY) AND SURGERY (LAPAROSCOPY). ON (B)(6) 2010, THE UTERINE PERFORATION HAD RESOLVED. AT THE TIME OF THE REPORT, THE GASTROINTESTINAL INJURY HAD RESOLVED AND THE LAST EPISODE OF COMPLICATION OF DEVICE INSERTION, BURSITIS AND ARTHRALGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ARTHRALGIA AND BURSITIS TO BE RELATED TO ESSURE. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR THE FIRST EPISODE OF COMPLICATION OF DEVICE INSERTION AND THE SECOND EPISODE OF COMPLICATION OF DEVICE INSERTION WITH ESSURE. THE REPORTER CONSIDERED GASTROINTESTINAL INJURY AND UTERINE PERFORATION TO BE UNRELATED TO ESSURE. THE REPORTER COMMENTED: THE PERFORATION WAS CAUSED BY THE SCOPE AND NOT ESSURE DEVICE. THE PATIENT HAD A HEMORRHAGE IN THE BOWEL AND THIS WAS CONTROLLED AND STOPPED. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED VIA SOCIAL MEDIA : BURSITIS, ARTHRALGIA". QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 30-OCT-2018: QUALITY SAFETY EVALUATION OF PTC (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

    NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("UTERINE PERFORATION WAS CAUSED BY THE SCOPE") AND GASTROINTESTINAL INJURY ("PERFORATION IN THE BOWEL") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2010, DURING ESSURE PROCEDURE INSERTION, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PROCEDURAL HAEMORRHAGE. ON (B)(6) 2010, THE PATIENT EXPERIENCED GASTROINTESTINAL INJURY (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH INTESTINAL HAEMORRHAGE, THE FIRST EPISODE OF COMPLICATION OF DEVICE INSERTION ("DEVICE INSERTION COMPLICATION") AND THE SECOND EPISODE OF COMPLICATION OF DEVICE INSERTION ("ESSURE INSERTION FAILED"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED BURSITIS ("I HAD BURSITIS") AND ARTHRALGIA ("HIP PAIN"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPY/ HYSTERECTOMY) . ON (B)(6) 2010, THE UTERINE PERFORATION HAD RESOLVED. AT THE TIME OF THE REPORT, THE GASTROINTESTINAL INJURY HAD RESOLVED AND THE LAST EPISODE OF COMPLICATION OF DEVICE INSERTION, BURSITIS AND ARTHRALGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ARTHRALGIA AND BURSITIS TO BE RELATED TO ESSURE. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR THE FIRST EPISODE OF COMPLICATION OF DEVICE INSERTION AND THE SECOND EPISODE OF COMPLICATION OF DEVICE INSERTION WITH ESSURE. THE REPORTER CONSIDERED GASTROINTESTINAL INJURY AND UTERINE PERFORATION TO BE UNRELATED TO ESSURE. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED VIA SOCIAL MEDIA : BURSITIS, ARTHRALGIA". MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: EVENTS- "I HAD BURSITIS, HIP PAIN" ADDED FROM SOCIAL MEDIA REPORT. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528658 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R