BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7925389 · Received October 2, 2018

    Report

    Report Number
    2951250-2018-04191
    Event Type
    Injury
    Date Received
    October 2, 2018
    Report Date
    November 29, 2018
    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 AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("I HAVE THEM HANGING OUT OF MY TUBE/ ONE OF THEM IS OUT OF ITS PLACE") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DEFECTIVE "THEY TELL ME THEIR DEFECTIVE" AND DEVICE DEPLOYMENT ISSUE "WHOEVER PLACED MY ESSURE PLACED THEM WRONG". ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("I AM IN A LOT OF PAIN / I AM GOING THROUGH A LOT OF PAIN") AND ADVERSE REACTION ("I AM HAVING A LOT OF COMPLICATIONS"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN AND ADVERSE REACTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ADVERSE REACTION, DEVICE DISLOCATION AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE WENT TO EMERGENCY ROOM DUE TO COMPLICATIONS. SHE WANTS ESSURE REMOVAL AND WAS CONSIDERING GETTING A LAWYER. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-NOV-2018: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. INCIDENT: NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. 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 CONSUMER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("I HAVE THEM HANGING OUT OF MY TUBE/ONE OF THEM IS OUT OF ITS PLACE") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DEFECTIVE "THEY TELL ME THEIR DEFECTIVE" AND DEVICE DEPLOYMENT ISSUE "WHOEVER PLACED MY ESSURE PLACED THEM WRONG". ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("I AM IN A LOT OF PAIN/I AM GOING THROUGH A LOT OF PAIN") AND ADVERSE REACTION ("I AM HAVING A LOT OF COMPLICATIONS"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN AND ADVERSE REACTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ADVERSE REACTION, DEVICE DISLOCATION AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE WENT TO EMERGENCY ROOM DUE TO COMPLICATIONS. SHE WANTS ESSURE REMOVAL AND WAS CONSIDERING GETTING A LAWYER. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-OCT-2018: FOLLOWING COMPANY INTERNAL CODING REVIEW, THE REPORTED EVENT "WHOEVER PLACED MY ESSURE PLACED THEM WRONG/I HAVE THEM HANGING OUT OF MY TUBE/ONE OF THEM IS OUT OF ITS PLACE" WAS SPLIT TO THE MEDDRA LLT: DEVICE PLACEMENT AT INCORRECT LOCATION AND MEDDRA LLT: DEVICE DISLOCATION. INCIDENT: NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766486 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other