BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 8626682 · Received May 21, 2019

    Report

    Report Number
    2951250-2019-01991
    Event Type
    Injury
    Date Received
    May 21, 2019
    Report Date
    June 10, 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 BACK PAIN ('I AM STILL HAVING A TON OF LOWER BACK PAIN / I HAD MY E-HELL REMOVED 17 DAYS AGO') 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 BACK PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PAIN IN EXTREMITY ("TOES HURTS/THROBBING PAINS DOWN MY LEGS/PAIN IN FEET AND TOES"), JOINT SWELLING ("MY ANKLES SWELLS UP"), ARTHRALGIA ("PAIN IN ANKLES"), HYPERAESTHESIA ("CAN'T STAND THE SLIGHTEST TOUCH") AND PELVIC PAIN ("EXTREME STABBING PAIN"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE BACK PAIN HAD NOT RESOLVED AND THE PAIN IN EXTREMITY, JOINT SWELLING, ARTHRALGIA, HYPERAESTHESIA AND PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ARTHRALGIA, BACK PAIN, HYPERAESTHESIA, JOINT SWELLING, PAIN IN EXTREMITY AND PELVIC PAIN TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WAS/WERE REPORTED FROM SOCIAL MEDIA REPORT: BACK PAIN, ARTHRALGIA, PAIN IN EXTREMITY, JOINT SWELLING AND HYPERAESTHESIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. AMENDMENT: THE REPORT WAS AMENDED FOR THE FOLLOWING REASON: THIS IS RETENTION CASE. ALL THE INFORMATION HAS BEEN TRANSFERRED FROM DELETION 2020-07354 .REFERENCES , REPORTERS INFORMATION AND EVENT :EXTREME STABBING PAIN WERE UPDATED. NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. 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 BACK PAIN ('I AM STILL HAVING A TON OF LOWER BACK PAIN / I HAD MY E-HELL REMOVED 17 DAYS AGO') 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 BACK PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PAIN IN EXTREMITY ("TOES HURTS/THROBBING PAINS DOWN MY LEGS/PAIN IN FEET AND TOES"), JOINT SWELLING ("MY ANKLES SWELLS UP"), ARTHRALGIA ("PAIN IN ANKLES") AND HYPERAESTHESIA ("CAN'T STAND THE SLIGHTEST TOUCH"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE BACK PAIN HAD NOT RESOLVED AND THE PAIN IN EXTREMITY, JOINT SWELLING, ARTHRALGIA AND HYPERAESTHESIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ARTHRALGIA, BACK PAIN, HYPERAESTHESIA, JOINT SWELLING AND PAIN IN EXTREMITY TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WAS/WERE REPORTED FROM SOCIAL MEDIA REPORT: BACK PAIN, ARTHRALGIA, PAIN IN EXTREMITY, JOINT SWELLING AND HYPERAESTHESIA. 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 EVENTS ADDED: TOES HURTS/THROBBING PAINS DOWN MY LEGS, MY ANKLES SWELLS UP, PAIN IN ANKLES AND CAN'T STAND THE SLIGHTEST TOUCH. 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.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF BACK PAIN ('I AM STILL HAVING A TON OF LOWER BACK PAIN / I HAD MY E-HELL REMOVED 17 DAYS AGO') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED BACK PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (SURGERY TO REMOVE ESSURE DEVICE). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE BACK PAIN HAD NOT RESOLVED. THE REPORTER CONSIDERED BACK PAIN TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WAS/WERE REPORTED FROM SOCIAL MEDIA REPORT: BACK PAIN. 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 INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420908 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R