BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7094799 · Received December 7, 2017

    Report

    Report Number
    2951250-2017-10135
    Event Type
    Injury
    Date Received
    December 7, 2017
    Date of Event
    November 1, 2017
    Report Date
    July 16, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY (NO COMPLICATIONS)") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED HYPERTENSION IN 2004. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR TO PREVENT PREGNANCY: DEPO PROVERA FROM 2003 TO 2005 AND IMPLANON FROM 1993 TO 2003. CONCOMITANT PRODUCTS INCLUDED AMLODIPINE SINCE 2004 AND LISINOPRIL SINCE 2004. IN (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED PERIPHERAL SWELLING ("SWELLING HANDS"). IN (B)(6) 2016, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"). IN (B)(6) 2017, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN (B)(6) 2017, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). IN (B)(6) 2017, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, MIGRAINE, HEADACHE, DYSMENORRHOEA AND ABDOMINAL PAIN LOWER HAD NOT RESOLVED AND THE PERIPHERAL SWELLING OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS UNKNOWN TO THE REPORTER. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, DYSMENORRHOEA, HEADACHE, MIGRAINE, PELVIC PAIN, PERIPHERAL SWELLING AND PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE HAD THE NEED FOR ADDITIONAL SURGERY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) 2010: TOTAL BILATERAL OCCLUSION MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-JUN-2018: PLAINTIFF FACT SHEET RECEIVED. NEW REPORTERS ADDED. PATIENT DEMOGRAPHIC INFORMATION AND PATIENT RELEVANT HISTORY ADDED. ESSURE INSERTION DATE UPDATED TO (B)(6) 2012. INDICATION (PERMANENT BIRTH CONTROL BY BILATERAL OCCLUSION OF THE FALLOPIAN TUBES) ADDED. CONCOMITANT MEDICATIONS ADDED. EVENTS PREGNANCY (NO COMPLICATIONS), DEVICE INEFFECTIVE, MIGRAINES, HEADACHES, DYSMENORRHEA (CRAMPING), SWELLING HANDS AND LOWER ABDOMINAL PAIN ADDED ON 18-JUN-2018: PREGNANCY WAS CHANGED FROM "UNK" TO "YES" 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 ("PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE HAD THE NEED FOR ADDITIONAL SURGERY. 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
    875012 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other| R AMLODIPINE| LISINOPRIL