BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6942230 · Received October 11, 2017

    Report

    Report Number
    2951250-2017-04539
    Event Type
    Injury
    Date Received
    October 11, 2017
    Date of Event
    January 1, 2012
    Report Date
    August 14, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("CHRONIC PELVIC PAIN") AND GENITAL HAEMORRHAGE ("EXCESSIVE ABNORMAL BLEEDING") IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 862629) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "ESSURE WAS PLACED WITH SLIGHT DIFFICULTY SECONDARY TO TUBAL SPASM". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED UTERINE BLEEDING. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING") AND MENORRHAGIA ("MENORRHAGIA"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)). AT THE TIME OF THE REPORT, THE PELVIC PAIN HAD RESOLVED AND THE GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE AND MENORRHAGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-JUN-2018: PFS AND MEDICAL RECORD RECEIVED:THE EVENT VAGINAL BLEEDING,MENORRHAGIA,DEVICE DIFFICULT TO INSERT ADDED. LAB DATA,EVENT OUTCOME,REPORTERS,LOT NUMBER, EXPIRATION DATE, PRODUCT STOP DATE 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.

    Additional Manufacturer Narrative · 0

    SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("CHRONIC PELVIC PAIN/PELVIC PAIN"), PELVIC INFLAMMATORY DISEASE ("PID FROM ENTERIC PATHOGEN") AND GENITAL HAEMORRHAGE ("EXCESSIVE ABNORMAL BLEEDING/ABNORMAL BLEEDING ") IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 862629) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "ESSURE WAS PLACED WITH SLIGHT DIFFICULTY SECONDARY TO TUBAL SPASM". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED UTERINE BLEEDING AND CHRONIC CERVICITIS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2016, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND MENORRHAGIA ("MENORRHAGIA/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES), HYSTERECTOMY TOTAL,ENDOMETRIAL BIOPSY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE AND MENORRHAGIA HAD RESOLVED AND THE PELVIC INFLAMMATORY DISEASE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: PELVIC INFLAMMATORY DISEASE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PFS AND MR RECEIVED. EVENTS PER MR: PELVIC INFLAMMARORY DISEASE WAS ADDED, OUTCOME OF THE EVENTS WERE UPDATED. 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

    THE SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC INFLAMMATORY DISEASE ("PID FROM ENTERIC PATHOGEN"), PELVIC PAIN ("CHRONIC PELVIC PAIN/PELVIC PAIN") AND GENITAL HAEMORRHAGE ("EXCESSIVE ABNORMAL BLEEDING/ABNORMAL BLEEDING") IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 862629(INVALID)) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "ESSURE WAS PLACED WITH SLIGHT DIFFICULTY SECONDARY TO TUBAL SPASM". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED UTERINE BLEEDING AND CHRONIC CERVICITIS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2016, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND MENORRHAGIA ("MENORRHAGIA/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND FALLOPIAN TUBE SPASM ("ESSURE WAS PLACED WITH SLIGHT DIFFICULTY SECONDARY TO TUBAL SPASM"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES), HYSTERECTOMY TOTAL,ENDOMETRIAL BIOPSY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC INFLAMMATORY DISEASE AND FALLOPIAN TUBE SPASM OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE AND MENORRHAGIA HAD RESOLVED. THE REPORTER CONSIDERED FALLOPIAN TUBE SPASM, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: PELVIC INFLAMMATORY DISEASE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-AUG-2018: UPDATE OF INFORMATION (BATCH IS INVALID). ENTRY OF FDA CODES, EMAIL CONFIRMATION FROM QA ATTACHED. INCIDENT NO VALID 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 ("CHRONIC PELVIC PAIN") AND GENITAL HAEMORRHAGE ("EXCESSIVE ABNORMAL BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A HYSTERECTOMY). AT THE TIME OF THE REPORT, THE PELVIC PAIN AND GENITAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED GENITAL HAEMORRHAGE AND PELVIC PAIN 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
    719664 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 862629(INVALID)

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other| R