BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9976635 · Received April 20, 2020

    Report

    Report Number
    2951250-2020-04530
    Event Type
    Injury
    Date Received
    April 20, 2020
    Report Date
    May 28, 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 EMBEDDED DEVICE ('APPARENTLY THE COIL HAD MIGRATED AND WAS GETTING HOOKED') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. 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 EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND PELVIC PAIN ("PAIN ALWAYS IN MY LEFT SIDE") AND WAS FOUND TO HAVE WEIGHT DECREASED ("I¿VE LOST 50IBS "). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE, PELVIC PAIN AND WEIGHT DECREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED EMBEDDED DEVICE, PELVIC PAIN AND WEIGHT DECREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SINCE DONE: (B)(6) 2016. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-MAR-2020: SOCIAL MEDIA RECEIVED. NEW EVENT I¿VE LOST 50IBS WAS ADDED. REPORTER WAS 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.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF EMBEDDED DEVICE ('APPARENTLY THE COIL HAD MIGRATED AND WAS GETTING HOOKE') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. 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 EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND PELVIC PAIN ("PAIN ALWAYS IN MY LEFT SIDE") AND WAS FOUND TO HAVE WEIGHT DECREASED ("I¿VE LOST 50IBS "). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE, PELVIC PAIN AND WEIGHT DECREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED EMBEDDED DEVICE, PELVIC PAIN AND WEIGHT DECREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SINCE DONE: (B)(6) 2016. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-MAY-2020: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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 EMBEDDED DEVICE ('APPARENTLY THE COIL HAD MIGRATED AND WAS GETTING HOOKE') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. 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 EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND PELVIC PAIN ("PAIN ALWAYS IN MY LEFT SIDE"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE AND PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED EMBEDDED DEVICE AND PELVIC PAIN TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440981 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R