BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 8814663 · Received July 23, 2019

    Report

    Report Number
    2951250-2019-04096
    Event Type
    Injury
    Date Received
    July 23, 2019
    Report Date
    July 23, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: OTHER TISSUE') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), MIGRAINE ("MIGRAINES/HEADACHES"), DEPRESSION ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: DEPRESSION"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), PELVIC PAIN ("PELVIC PAIN"), BACK PAIN ("BACK PAIN"), ABDOMINAL PAIN ("ABDOMEN PAIN") AND ALOPECIA ("HAIR LOSS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE) GAIN"). THE PATIENT WAS TREATED WITH SURGERY (SURGICAL REMOVAL OF COIL(S)). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, VAGINAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, DEPRESSION, DYSMENORRHOEA, PELVIC PAIN, BACK PAIN, ABDOMINAL PAIN, WEIGHT INCREASED AND ALOPECIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, BACK PAIN, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, MENORRHAGIA, MIGRAINE, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AGE DISCREPANCY NOTED AS PATIENTS DATE OF BIRTH WAS REPORTED: (B)(6). QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-JUL-2019: NEW PFS RECEIVED. CASE BECOMES INCIDENT. EVENT INJURY NOS REPLACED WITH NEW EVENTS: MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: OTHER TISSUE, ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), MIGRAINES / HEADACHES, DEPRESSION, DYSMENORRHEA (CRAMPING), PELVIC PAIN, BACK PAIN, ABDOMINAL PAIN, WEIGHT GAIN, HAIR LOSS. REPORTER WAS ADDED. WEIGHT LOSS EVENT DELETED INCIDENT: NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610077 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R