BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 8784100 · Received July 12, 2019

    Report

    Report Number
    2951250-2019-03769
    Event Type
    Injury
    Date Received
    July 12, 2019
    Report Date
    July 12, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, 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 ('ESSURE IS EMBEDDED IN MY OVARIES') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE 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 "DID NOT UNDERGO ESSURE CONFIRMATION TEST.". ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2016, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), 104 DAYS BEFORE INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PAIN/ PELVIC PAIN") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE DISLOCATION, DYSMENORRHOEA, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN DATE OF INSERTION- (B)(6) 2016, (B)(6) 2015. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-JUL-2019: PFS RECEIVED- NEW EVENTS ABNORMAL BLEEDING (MENORRHAGIA), DYSMENORRHEA (CRAMPING), PAIN, DID NOT UNDERGO ESSURE CONFIRMATION TEST, ESSURE IS EMBEDDED IN MY OVARIES WERE ADDED. EVENT INJURY UPDATED TO ABNORMAL BLEEDING (VAGINAL). NEW REPORTER, PATIENT INFORMATION WERE ADDED. 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
    577595 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other| R