BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6793830 · Received August 15, 2017

    Report

    Report Number
    2951250-2017-02901
    Event Type
    Injury
    Date Received
    August 15, 2017
    Report Date
    February 14, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A PHYSICIAN AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922613) INSERTED FOR PRODUCT USED FOR UNKNOWN INDICATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED CHOLECYSTECTOMY AND UMBILICAL HERNIA REPAIR. CONCURRENT CONDITIONS INCLUDED MENORRHAGIA. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), ABDOMINAL PAIN LOWER ("CRAMPING") AND WEIGHT DECREASED ("WEIGHT LOSS"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROTOMY WITH BILATERAL SALPHOGENECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER AND WEIGHT DECREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, PELVIC PAIN AND WEIGHT DECREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: REMOVAL WAS PERFORMED DUE TO MEDICAL REASON AND AT PATIENT'S REQUEST. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE (B)(6) KGS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT : MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-FEB-2018: QUALITY-SAFETY EVALUATION OF PTC. UPDATE OF FDA CODES, ADDITION OF BATCH NUMBER DATES 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 · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A PHYSICIAN AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN"), MENORRHAGIA ("MENORRHAGIA"), ABDOMINAL PAIN ("ABDOMINAL PAIN "), ABDOMINAL PAIN LOWER ("CRAMPING") AND WEIGHT DECREASED ("WEIGHT LOSS") IN AN ADULT PATIENT WHO HAD ESSURE INSERTED FOR PRODUCT USED FOR UNKNOWN INDICATION. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN, MENORRHAGIA, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER AND WEIGHT DECREASED. THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER AND WEIGHT DECREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, MENORRHAGIA, PELVIC PAIN AND WEIGHT DECREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE (B)(6) KGS. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 25-OCT-2017: PATIENT DEMOGRAPHIC, PRODUCT INFORMATION UPDATE AND EVENT 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 PHYSICIAN AND DESCRIBES THE OCCURRENCE OF ADVERSE EVENT ("PATIENT IS QUITE SURE THAT THAT THE ESSURE IS THE SOURCE OF HER PROBLEMS/I HAVE TALKED TO HER SO MANY TIMES ABOUT HER VARIOUS SYMPTOMS.") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR PRODUCT USED FOR UNKNOWN INDICATION. IN 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ADVERSE EVENT (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (PLAN TO DO A BILATERAL SALPHOGENECTOMY TODAY TO REMOVE THE ESSURE). IT WAS UNKNOWN WHETHER ANY ACTION WAS TAKEN WITH ESSURE. AT THE TIME OF THE REPORT, THE ADVERSE EVENT OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ADVERSE EVENT WITH 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
    575262 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 922613

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R