BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7531529 · Received May 22, 2018

    Report

    Report Number
    2951250-2018-02322
    Event Type
    Injury
    Date Received
    May 22, 2018
    Report Date
    October 30, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("DEVICE MIGRATION"), DEVICE EXPULSION ("EXCESS ESSURE COILS IN THE UTERUS") AND GENITAL HAEMORRHAGE ("UNUSUAL BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 12259784) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "ESSURE CONFIRMATION TEST CONDUCTED: NO". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED UTERINE BLEEDING, METRORRHAGIA, VAGINAL INFECTION, GASTRIC BYPASS, NEPHRECTOMY, VAGINAL DISCHARGE AND BARIATRIC SURGERY. ON (B)(6) 2005, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PAIN"), ABDOMINAL PAIN LOWER ("CRAMPING"), MENSTRUAL DISORDER ("UNUSUAL PERIODS"), MENORRHAGIA ("PROLONGED PERIODS") AND ARTHRALGIA ("JOINT PAIN"). THE PATIENT WAS TREATED WITH SURGERY (REMOVED THE MIGRATED PORTION FROM HER UTERUS), SURGERY (REMOVED THE MIGRATED PORTION FROM HER UTERUS) AND SURGERY (NOVASURE ABLATION ON (B)(6) 2015). AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, DEVICE EXPULSION, GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN LOWER, MENSTRUAL DISORDER, MENORRHAGIA AND ARTHRALGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ARTHRALGIA, DEVICE DISLOCATION, DEVICE EXPULSION, GENITAL HAEMORRHAGE, MENORRHAGIA, MENSTRUAL DISORDER AND PELVIC PAIN TO BE RELATED TO ESSURE (ESS205). QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. FURTHER COMPANY FOLLOW-UP WITH THE LAWYER OR LAWYER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 30-OCT-2018: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINTS. INCIDENT: AT THE TIME OF REPORTING, 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.

    Additional Manufacturer Narrative · 0

    NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("DEVICE MIGRATION"), DEVICE EXPULSION ("EXCESS ESSURE COILS IN THE UTERUS") AND GENITAL HAEMORRHAGE ("UNUSUAL BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 12259784) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "ESSURE CONFIRMATION TEST CONDUCTED: NO". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED UTERINE BLEEDING, METRORRHAGIA, VAGINAL INFECTION, GASTRIC BYPASS, NEPHRECTOMY, VAGINAL DISCHARGE AND BARIATRIC SURGERY. ON (B)(4) 2005, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PAIN"), ABDOMINAL PAIN LOWER ("CRAMPING"), MENSTRUAL DISORDER ("UNUSUAL PERIODS"), MENORRHAGIA ("PROLONGED PERIODS") AND ARTHRALGIA ("JOINT PAIN"). THE PATIENT WAS TREATED WITH SURGERY (REMOVED THE MIGRATED PORTION FROM HER UTERUS), SURGERY (REMOVED THE MIGRATED PORTION FROM HER UTERUS) AND SURGERY (NOVASURE ABLATION ON (B)(4) 2015). AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, DEVICE EXPULSION, GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN LOWER, MENSTRUAL DISORDER, MENORRHAGIA AND ARTHRALGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ARTHRALGIA, DEVICE DISLOCATION, DEVICE EXPULSION, MENORRHAGIA, MENSTRUAL DISORDER AND PELVIC PAIN TO BE RELATED TO ESSURE (ESS205). NO FURTHER CAUSALITY ASSESSMENT WERE PROVIDED FOR THE PRODUCT. FURTHER COMPANY FOLLOW-UP WITH THE LAWYER OR LAWYER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(4) 2018: PFS+MR RECEIVED: NEW EVENTS: DEVICE EXPULSION, DEVICE MONITORING PROCEDURE NOT PERFORMED AND PRODUCT LOT NUMBER, CONCOMITANT DISEASES ADDED. INCIDENT AT THE TIME OF REPORTING, 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 ("DEVICE MIGRATION") AND GENITAL HAEMORRHAGE ("UNUSUAL BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2005, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PAIN"), ABDOMINAL PAIN LOWER ("CRAMPING"), MENSTRUAL DISORDER ("UNUSUAL PERIODS"), MENORRHAGIA ("PROLONGED PERIODS") AND ARTHRALGIA ("JOINT PAIN"). THE PATIENT WAS TREATED WITH SURGERY (NOVASURE ABLATION ON (B)(6) 2015). AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN LOWER, MENSTRUAL DISORDER, MENORRHAGIA AND ARTHRALGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ARTHRALGIA, DEVICE DISLOCATION, GENITAL HAEMORRHAGE, MENORRHAGIA, MENSTRUAL DISORDER AND PELVIC PAIN TO BE RELATED TO ESSURE (ESS205). FURTHER COMPANY FOLLOW-UP WITH THE LAWYER OR LAWYER IS NOT POSSIBLE. 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
    376465 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS205 12259784

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R