BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7198622 · Received January 17, 2018

    Report

    Report Number
    2951250-2018-00422
    Event Type
    Injury
    Date Received
    January 17, 2018
    Report Date
    July 26, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("DEVICE MIGRATION") AND GENITAL HAEMORRHAGE ("UNUSUAL BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952114) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), MENOMETRORRHAGIA ("IRREGULAR AND PROLONGED MENSTRUATION"), DYSPAREUNIA ("PAIN DURING INTERCOURSE"), ABDOMINAL PAIN LOWER ("CRAMPING"), ABDOMINAL DISTENSION ("BLOATING"), RASH ("RASHES"), ALOPECIA ("HAIR LOSS"), MIGRAINE ("MIGRAINE"), PELVIC PAIN ("PELVIC PAIN") AND MENSTRUAL DISORDER ("UNUSUAL MENSTRUAL CYCLES"). THE PATIENT WAS TREATED WITH NAPROXEN SODIUM (ALEVE). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE, DYSMENORRHOEA, MENOMETRORRHAGIA, ABDOMINAL PAIN, DYSPAREUNIA, ABDOMINAL PAIN LOWER, ABDOMINAL DISTENSION, RASH, ALOPECIA, MIGRAINE, PELVIC PAIN AND MENSTRUAL DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALOPECIA, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENOMETRORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, PELVIC PAIN AND RASH TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF DID NOT HAVE ESSURE REMOVAL. DISCREPANCY NOTED THAT FOR ESSURE CONFIRMATION TEST : NO (PREVIOUSLY REPORTED AS HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: FALLOPIAN TUBES WERE OCCLUDED). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: FALLOPIAN TUBES WERE OCCLUDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PFS RECEIVED - NEW EVENT "PELVIC PAIN, UNUSUAL BLEEDING, UNUSUAL MENSTRUAL CYCLES, ESSURE CONFIRMATION TEST DID NOT CONDUCTED" WERE ADDED. LOT NUMBER WAS ADDED. PRODUCT IMPLANT DATE WAS UPDATED. TREATMENT MEDICATION WAS ADDED. ON (B)(6) 2018: NARRATIVE WAS AMENDED. 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 LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("DEVICE MIGRATION") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), MENOMETRORRHAGIA ("IRREGULAR AND PROLONGED MENSTRUATION"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSPAREUNIA ("PAIN DURING INTERCOURSE"), ABDOMINAL PAIN LOWER ("CRAMPING"), ABDOMINAL DISTENSION ("BLOATING"), RASH ("RASHES"), ALOPECIA ("HAIR LOSS") AND MIGRAINE ("MIGRAINE"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, DYSMENORRHOEA, MENOMETRORRHAGIA, ABDOMINAL PAIN, DYSPAREUNIA, ABDOMINAL PAIN LOWER, ABDOMINAL DISTENSION, RASH, ALOPECIA AND MIGRAINE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALOPECIA, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, MENOMETRORRHAGIA, MIGRAINE AND RASH TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF MAY NOW HAVE TO UNDERGO A HYSTERECTOMY IN THE FUTURE TO REMOVE THE ESSURE DEVICE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: FALLOPIAN TUBES WERE OCCLUDED. 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
    45234 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 952114

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R