BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7523643 · Received May 17, 2018

    Report

    Report Number
    2951250-2018-02220
    Event Type
    Injury
    Date Received
    May 17, 2018
    Date of Event
    January 1, 2013
    Report Date
    February 7, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN /PAIN") IN A 38-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822376) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERWENT ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED MIGRAINE, SPIDER BITE, TACHYCARDIA AND BREAST MASS. CONCOMITANT PRODUCTS INCLUDED ALLOPURINOL (ELAVIL), PROPRANOLOL HYDROCHLORIDE (PROPANOLOL), SERTRALINE HYDROCHLORIDE (ZOLOFT), TIZANIDINE HYDROCHLORIDE (ZANAFLEX) AND TOPIRAMATE (TOPAMAX). IN 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND BACK PAIN ("BACK PAIN"). ON (B)(6)2013, THE PATIENT HAD ESSURE INSERTED. ON (B)(6)2013, THE PATIENT EXPERIENCED THE FIRST EPISODE OF MENORRHAGIA ("ABNORMAL AND EXCESSIVE BLEEDING DURING MENSTRUATION") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), 2 DAYS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED THE SECOND EPISODE OF MENORRHAGIA ("MENORRHAGIA"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES), OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6)2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN AND VAGINAL HAEMORRHAGE HAD RESOLVED AND THE BACK PAIN AND THE LAST EPISODE OF MENORRHAGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, PELVIC PAIN, VAGINAL HAEMORRHAGE, THE FIRST EPISODE OF MENORRHAGIA AND THE SECOND EPISODE OF MENORRHAGIA TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)2019: PLAINTIFF FACT SHEET- EVENTS ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA) AND SHE DID NOT UNDERWENT ESSURE CONFIRMATION TEST WERE ADDED. INCIDENT: WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Additional Manufacturer Narrative · 0

    NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN") AND MENORRHAGIA ("ABNORMAL AND EXCESSIVE BLEEDING DURING MENSTRUATION"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY ON (B)(6) 2013). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN AND MENORRHAGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, MENORRHAGIA AND PELVIC PAIN TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-JUL-2018: QUALITY SAFETY EVALUATION OF 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.

    Additional Manufacturer Narrative · 0

    NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN") AND MENORRHAGIA ("ABNORMAL AND EXCESSIVE BLEEDING DURING MENSTRUATION"). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY ON (B)(6) 2013). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN AND MENORRHAGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, MENORRHAGIA AND PELVIC PAIN TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-JUL-2018: QUALITY SAFETY EVALUATION OF PTC. 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 ("PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN") AND MENORRHAGIA ("ABNORMAL AND EXCESSIVE BLEEDING DURING MENSTRUATION"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY ON (B)(6) 2013). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN AND MENORRHAGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, MENORRHAGIA 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
    365599 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 822376

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other| R ELAVIL [ALLOPURINOL]| PROPANOLOL [PROPRANOLOL HYDROCHLORIDE]| TOPAMAX| ZANAFLEX| ZOLOFT