BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 8810785 · Received July 22, 2019

    Report

    Report Number
    2951250-2019-04054
    Event Type
    Injury
    Date Received
    July 22, 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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('AFTER GETTING HYSTERECTOMY') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND EXPERIENCED BREAST PAIN ("SORE BREAST"), NAUSEA ("FEEL SICK TO STOMACH/FEELING SICK TO MY BELLY"), PAIN ("BODY ACHES"), ASTHENIA ("BODY GETTING VERY SLEEPY"), ABDOMINAL DISTENSION ("FEEL BLOATED/BUBBLE MOVEMENTS IN MY STOMACH"), ILL-DEFINED DISORDER ("LITTLE ILLNESS") AND BACK PAIN ("BACK PAIN"). THE PATIENT WAS TREATED WITH SURGERY (SHE UNDERGONE HYSTERECTOMY ON AN UNSPECIFIED DATE). AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL, BREAST PAIN, NAUSEA, PAIN, ASTHENIA, ABDOMINAL DISTENSION, ILL-DEFINED DISORDER AND BACK PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ASTHENIA, BACK PAIN, BREAST PAIN, ILL-DEFINED DISORDER, MEDICAL DEVICE REMOVAL, NAUSEA AND PAIN TO BE RELATED TO ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: THIS RECORD WAS DETECTED TO BE A DUPLICATE TO CASE# US-BAYER-2017-130143 TO WHICH ALL INFORMATION WILL BE TRANSFERRED. THEN THIS DUPLICATE CASE (US-BAYER-2019-136393) WILL BE DELETED NO LOT NUMBER 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-CONFORMANCE'S DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('AFTER GETTING HYSTERECTOMY') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND EXPERIENCED BREAST PAIN ("SORE BREAST"), NAUSEA ("FEEL SICK TO STOMACH/FEELING SICK TO MY BELLY"), PAIN ("BODY ACHES"), ASTHENIA ("BODY GETTING VERY SLEEPY"), ABDOMINAL DISTENSION ("FEEL BLOATED/BUBBLE MOVEMENTS IN MY STOMACH"), ILL-DEFINED DISORDER ("LITTLE ILLNESS") AND BACK PAIN ("BACK PAIN"). THE PATIENT WAS TREATED WITH SURGERY (SHE UNDERGONE HYSTERECTOMY ON AN UNSPECIFIED DATE). AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL, BREAST PAIN, NAUSEA, PAIN, ASTHENIA, ABDOMINAL DISTENSION, ILL-DEFINED DISORDER AND BACK PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ASTHENIA, BACK PAIN, BREAST PAIN, ILL-DEFINED DISORDER, MEDICAL DEVICE REMOVAL, NAUSEA AND PAIN TO BE RELATED TO ESSURE. NO LOT NUMBER 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
    607133 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R