BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10394542 · Received August 12, 2020

    Report

    Report Number
    2951250-2020-13053
    Event Type
    Injury
    Date Received
    August 12, 2020
    Report Date
    August 19, 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 CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF EMBEDDED DEVICE ('EMBEDDED WITHIN THE LUMEN OF THE SECOND SEGMENT OF FALLOPIAN TUBE') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822376) INSERTED. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL SURGERY). ESSURE WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED EMBEDDED DEVICE TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: EMBEDDED DEVICE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-AUG-2020: QUALITY SAFETY EVALUATION OF PTC(PRODUCT TECHNICAL COMPLAINTS). WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS 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 CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF EMBEDDED DEVICE ('EMBEDDED WITHIN THE LUMEN OF THE SECOND SEGMENT OF FALLOPIAN TUBE') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822376) INSERTED. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL SURGERY). ESSURE WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED EMBEDDED DEVICE TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: EMBEDDED DEVICE QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860097 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 822376 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R