BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9238424 · Received October 25, 2019

    Report

    Report Number
    2951250-2019-10775
    Event Type
    Injury
    Date Received
    October 25, 2019
    Report Date
    June 5, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Product Problem
    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 DEVICE DISLOCATION ('HAD A COMPLETE, BUT SAW ONLY ONE EVIL SLINKY/FIND THE OTHER SINKY/NOT IN RIGHT PLACE') AND DEVICE BREAKAGE ('ON YOUR RIGHT THE ESSURE HAS FRAGMENTED') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. 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 EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ARTHRITIS ("JOINT INFLAMMATION") WITH ARTHRALGIA AND JOINT SWELLING, AUTOIMMUNE THYROIDITIS ("AUTOIMMUNE THYROIDITIS"), PELVIC PAIN ("YES: EXTREME STABBING PAIN IN THE CIRCLED LOCATION") AND HYPOTHYROIDISM ("HYPOTHYROID"). THE PATIENT WAS TREATED WITH SURGERY (ONE ESSURE COIL REMOVAL LEAVING OVARIES). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, DEVICE BREAKAGE, ARTHRITIS, AUTOIMMUNE THYROIDITIS, PELVIC PAIN AND HYPOTHYROIDISM OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ARTHRITIS, AUTOIMMUNE THYROIDITIS, DEVICE BREAKAGE, DEVICE DISLOCATION, HYPOTHYROIDISM AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: IT WAS REPORTED IN THE SOURCE DOCUMENT ONE EVIL SLINKY. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. AMENDMENT: THE REPORT WAS AMENDED FOR THE FOLLOWING REASON: INFORMATION TRANSFERRED FROM DELETION CASE 2019-189478 AND 2020-071570 - EVENTS ESSURE MICRO-INSERT MIGRATION, JOINT INFLAMMATION, SWOLLEN JOINTS, JOINTS ACHE, DEVICE BREAKAGE , PELVIC PAIN FEMALE, AUTOIMMUNE THYROIDITIS, HYPOTHYROID ADDED. REPORTER, ALL SOURCE DOCUMENTS AND REFERENCE SECTION WERE TRANSFERRED TO THIS CASE.2019-189478-LEGACY DEVICE REPORT NUM-2951250-2019-10862 2020-071570-LEGACY DEVICE REPORT NUM-2951250-2020-08218. NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION 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 ('COMPLETE REMOVAL LEAVING OVARIES') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. 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). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL OF ESSURE). AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: IT WAS REPORTED IN THE SOURCE DOCUMENT ONE EVIL SLINKY. CONCERNING THE INJURIES REPORTED IN THIS CASE THE FOLLOWING EVENTS WERE REPORTED VIA SOCIAL MEDIA: MEDICAL DEVICE REMOVAL. 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
    1032770 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R