BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10325787 · Received July 27, 2020

    Report

    Report Number
    2951250-2020-12263
    Event Type
    Injury
    Date Received
    July 27, 2020
    Report Date
    August 13, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('PERFORATION / MIGRATION / THE ESSURE DEVICE IN THE LEFT CUL-DE-SAC WAS GRASPED') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 884973-INV) INSERTED FOR FEMALE STERILIZATION. ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL (B)(6) 2017). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE DISLOCATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: COILS: LEFT 1, RIGHT ¿ 0. ESSURE REMOVAL DATE PROVIDED IN PIF : (B)(6) 2017. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: NORMAL PATENT RIGHT FALLOPIAN TUBE WITH NO COIL DEMONSTRATED. NORMAL PATENT OF THE LEFT TUBAL COIL. SECOND COIL IDENTIFIED IN THE LEFT LOWER HEMI PELVIS PROBABLY IN THE PERITONEAL CAVITY. LOT NUMBER 884973 IS INVALID. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-AUG-2020: QUALITY SAFETY EVALUATION OF PTC. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS 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 DEVICE DISLOCATION ('PERFORATION / MIGRATION / THE ESSURE DEVICE IN THE LEFT CUL-DE-SAC WAS GRASPED') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 884973) INSERTED FOR FEMALE STERILIZATION. ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL (B)(6) 2017). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE DISLOCATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: COILS: LEFT 1, RIGHT ¿ 0. ESSURE REMOVAL DATE PROVIDED IN PIF: (B)(6) 2017. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: NORMAL PATENT RIGHT FALLOPIAN TUBE WITH NO COIL DEMONSTRATED. NORMAL PATENT OF THE LEFT TUBAL COIL. SECOND COIL IDENTIFIED IN THE LEFT LOWER HEMI PELVIS PROBABLY IN THE PERITONEAL CAVITY. 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
    790041 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 884973-INV 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R