BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSURE

    MDR report key: 9105142 · Received September 23, 2019

    Report

    Report Number
    2951250-2019-07932
    Event Type
    Malfunction
    Date Received
    September 23, 2019
    Report Date
    October 16, 2019
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('DEVICE BREAKAGE') AND DEVICE DISLOCATION ('MIGRATION') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED FOR FEMALE STERILISATION. ON (B)(6) 2005, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ESSURE (ESS205) TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE AND DEVICE DISLOCATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE BREAKAGE AND DEVICE DISLOCATION TO BE RELATED TO ESSURE (ESS205). QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)2019: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. 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.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('DEVICE BREAKAGE') AND DEVICE DISLOCATION ('MIGRATION') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED FOR FEMALE STERILISATION. ON (B)(6) 2005, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ESSURE (ESS205) TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE AND DEVICE DISLOCATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE BREAKAGE AND DEVICE DISLOCATION TO BE RELATED TO ESSURE (ESS205). QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-SEP-2019: PFS RECEIVED. REPORTER AND PATIENT DEMOGRAPHICS WERE ADDED. UPDATED SUSPECT DRUG INDICATION. LAB DATA ADDED. EVENT INJURY NOS REPLACED WITH DEVICE BREAKAGE AND MIGRATION ADDED. INCIDENT: NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. 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
    898145 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS205 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other