BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10166954 · Received June 18, 2020

    Report

    Report Number
    2951250-2020-08934
    Event Type
    Injury
    Date Received
    June 18, 2020
    Report Date
    July 10, 2020
    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 URTICARIA CHRONIC ('CHRONIC HIVES') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922606) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED URTICARIA CHRONIC (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PRURITUS ("ITCHING"), URTICARIA ("HIVES"), ARTHRALGIA ("JOINT ACHE"), MYALGIA ("MUSCLES ACHE"), PANIC ATTACK ("PANIC ATTCKS") AND ANXIETY ("ANXIETY SO BAD"). THE PATIENT WAS TREATED WITH SURGERY (LAPARASCOPIC BILATERAL SALPINGECTOMIES AND REMOVAL OF ESSURE COILS). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE URTICARIA CHRONIC OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, ARTHRALGIA, MYALGIA, PANIC ATTACK, PRURITUS, URTICARIA AND URTICARIA CHRONIC TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: TUBAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-JUN-2020: PFS RECIVED, REPORTER, LOT NUMBER , LAB DATA ADDED. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT 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 URTICARIA CHRONIC ('CHRONIC HIVES') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED URTICARIA CHRONIC (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PRURITUS ("ITCHING"), URTICARIA ("HIVES"), ARTHRALGIA ("JOINT ACHE"), MYALGIA ("MUSCLES ACHE"), PANIC ATTACK ("PANIC ATTACKS") AND ANXIETY ("ANXIETY SO BAD"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE URTICARIA CHRONIC OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, ARTHRALGIA, MYALGIA, PANIC ATTACK, PRURITUS, URTICARIA AND URTICARIA CHRONIC TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-JAN-2020: PIF RECEIVED. CASE CATEGORY UPDATED TO SERIOUS INCIDENT. ESSURE REMOVAL DETAILS ADDED. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632699 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 922606 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R