BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7262792 · Received February 12, 2018

    Report

    Report Number
    2951250-2018-00605
    Event Type
    Injury
    Date Received
    February 12, 2018
    Report Date
    July 13, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    E WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FOOD AND DRUG ADMINISTRATION, REFERENCE NUMBER: MW5035674) ON (B)(6) 2014. THE MOST RECENT INFORMATION WAS RECEIVED ON (B)(6) 2018. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ("PERIODS HAVE BEEN EXTREMELY HEAVY") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 626400) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), METRORRHAGIA ("SPOT 3-4 DAYS BEFORE MY PERIOD WITH MILD ACHING PAIN"), DYSMENORRHOEA ("PAIN I GO THROUGH EACH MONTH IS GETTING WORSE / PERIOD WITH MILD ACHING PAIN") AND URINARY RETENTION POSTOPERATIVE ("HAVING TROUBLE URINATING (COULDNT GO AND THE NEXT DAY THEY PUT A CATH)"). THE PATIENT WAS TREATED WITH SURGERY (HYSTEROCTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MENORRHAGIA, METRORRHAGIA, DYSMENORRHOEA AND URINARY RETENTION POSTOPERATIVE OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR DYSMENORRHOEA, MENORRHAGIA AND METRORRHAGIA WITH ESSURE. THE REPORTER CONSIDERED URINARY RETENTION POSTOPERATIVE TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA SOCIAL MEDIA REMOVAL OF ESSURE VIA HYSTEROCTOMY AND URINARY RETENTION POSTOPERATIVE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-JUL-2018: QUALITY SAFETY EVALUATION OF PTC 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

    THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FOOD AND DRUG ADMINISTRATION, REFERENCE NUMBER: MW5035674) ON 27-MAY-2014. THE MOST RECENT INFORMATION WAS RECEIVED ON 01-FEB-2018. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ("PERIODS HAVE BEEN EXTREMELY HEAVY") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 626400) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), METRORRHAGIA ("SPOT 3-4 DAYS BEFORE MY PERIOD WITH MILD ACHING PAIN"), DYSMENORRHOEA ("PAIN I GO THROUGH EACH MONTH IS GETTING WORSE / PERIOD WITH MILD ACHING PAIN") AND URINARY RETENTION POSTOPERATIVE ("HAVING TROUBLE URINATING (COULDNT GO AND THE NEXT DAY THEY PUT A CATH)"). THE PATIENT WAS TREATED WITH SURGERY (HYSTEROCTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MENORRHAGIA, METRORRHAGIA, DYSMENORRHOEA AND URINARY RETENTION POSTOPERATIVE OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR DYSMENORRHOEA, MENORRHAGIA AND METRORRHAGIA WITH ESSURE. THE REPORTER CONSIDERED URINARY RETENTION POSTOPERATIVE TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA SOCIAL MEDIA REMOVAL OF ESSURE VIA HYSTEROCTOMY AND URINARY RETENTION POSTOPERATIVE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-FEB-2018: SIGNIFICANT CASE CORRECTION- EVENT HAVING TROUBLE URINATING (COULDNT GO AND THE NEXT DAY THEY PUT A CATH). 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 CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FOOD AND DRUG ADMINISTRATION, REFERENCE NUMBER: MW5035674) ON 27-MAY-2014. THE MOST RECENT INFORMATION WAS RECEIVED ON 01-FEB-2018. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ("PERIODS HAVE BEEN EXTREMELY HEAVY") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 626400) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), METRORRHAGIA ("SPOT 3-4 DAYS BEFORE MY PERIOD WITH MILD ACHING PAIN") AND DYSMENORRHOEA ("PAIN I GO THROUGH EACH MONTH IS GETTING WORSE / PERIOD WITH MILD ACHING PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MENORRHAGIA, METRORRHAGIA AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR DYSMENORRHOEA, MENORRHAGIA AND METRORRHAGIA WITH ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA SOCIAL MEDIA HYSTERECTOMY. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-FEB-2018: CASE BECAME INCIDENT. (HYSTERECTOMY MARKED AS SURGERY). PATIENT AND REPORTER INFORMATION UPDATED.¿ESSURE LEGAL MANUFACTURE HAS CHANGED FROM BAYER HEALTHCARE, LLC, (B)(4) TO BAYER PHARMA (B)(4), 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
    107684 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 626400

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R