BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10014666 · Received April 30, 2020

    Report

    Report Number
    2951250-2020-06330
    Event Type
    Injury
    Date Received
    April 30, 2020
    Report Date
    May 7, 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 DEVICE DISLOCATION ('MY LEFT COIL BROKE BUT DIDN'T GO FAR') AND DEVICE BREAKAGE ('MY LEFT COIL BROKE BUT DIDN'T GO FAR') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED ABNORMAL CLOTTING FACTOR AND PARITY 2. IN (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED MULTIPLE SCLEROSIS ("I HAVE MS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ARTHRALGIA ("PAIN"), MYALGIA ("SORE MUSCLE"), HEADACHE ("HEADACHE"), FEELING ABNORMAL ("FEEL LIKE I AM OLD AND CRIPPLE"), BACK PAIN ("LOWER BACK START TO HURT AFTER WALKING"), GAIT INABILITY ("COULD NOT WALK THUR A STORE"), ABDOMINAL DISTENSION ("BLOATING LOOKING PREGNANT") AND PAIN ("ALL THE PAIN WE TAKE OR TOOKEN WITH IT") AND WAS FOUND TO HAVE WEIGHT INCREASED ("NEED TO LOSE THE WEIGHT GAIN") AND WEIGHT DECREASED ("WEIGHT DROP, 220, 200, 190"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, DEVICE BREAKAGE, ARTHRALGIA, MYALGIA, HEADACHE, FEELING ABNORMAL, WEIGHT INCREASED, ABDOMINAL DISTENSION AND WEIGHT DECREASED OUTCOME WAS UNKNOWN, THE MULTIPLE SCLEROSIS HAD NOT RESOLVED AND THE BACK PAIN AND PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ARTHRALGIA, BACK PAIN, DEVICE BREAKAGE, DEVICE DISLOCATION, FEELING ABNORMAL, GAIT INABILITY, HEADACHE, MULTIPLE SCLEROSIS, MYALGIA, PAIN, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: I'M 215 DEPENDING ON MY DAYS GOES UP AND DOWN BUT MAINLY 215 AND NO BACK ISSUES NO NOTHING NO PAIN I FEEL NORMAL AS I DID BEFORE ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-MAY-2020: QUALITY SAFETY EVALUATION OF PTC. MEDICAL DEVICE REMOVAL EVENT WAS DELETED. 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 MEDICAL DEVICE REMOVAL ('SURGERY'), DEVICE DISLOCATION ('MY LEFT COIL BROKE BUT DIDN'T GO FAR') AND DEVICE BREAKAGE ('MY LEFT COIL BROKE BUT DIDN'T GO FAR') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED ABNORMAL CLOTTING FACTOR AND PARITY 2. IN (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED MULTIPLE SCLEROSIS ("I HAVE MS"). ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ARTHRALGIA ("PAIN"), MYALGIA ("SORE MUSCLE"), HEADACHE ("HEADACHE"), FEELING ABNORMAL ("FEEL LIKE I AM OLD AND CRIPPLE"), BACK PAIN ("LOWER BACK START TO HURT AFTER WALKING"), GAIT INABILITY ("COULD NOT WALK THRU A STORE"), ABDOMINAL DISTENSION ("BLOATING LOOKING PREGNANT") AND PAIN ("ALL THE PAIN WE TAKE OR TOOK WITH IT") AND WAS FOUND TO HAVE WEIGHT INCREASED ("NEED TO LOSE THE WEIGHT GAIN") AND WEIGHT DECREASED ("WEIGHT DROP, (B)(6)"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL, DEVICE DISLOCATION, DEVICE BREAKAGE, ARTHRALGIA, MYALGIA, HEADACHE, FEELING ABNORMAL, WEIGHT INCREASED, ABDOMINAL DISTENSION AND WEIGHT DECREASED OUTCOME WAS UNKNOWN, THE MULTIPLE SCLEROSIS HAD NOT RESOLVED AND THE BACK PAIN AND PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ARTHRALGIA, BACK PAIN, DEVICE BREAKAGE, DEVICE DISLOCATION, FEELING ABNORMAL, GAIT INABILITY, HEADACHE, MEDICAL DEVICE REMOVAL, MULTIPLE SCLEROSIS, MYALGIA, PAIN, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: I'M (B)(6) DEPENDING ON MY DAYS GOES UP AND DOWN BUT MAINLY (B)(6) AND NO BACK ISSUES NO NOTHING NO PAIN I FEEL NORMAL AS I DID BEFORE 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 WILL BE 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
    477772 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R