BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 8459100 · Received March 28, 2019

    Report

    Report Number
    2951250-2019-01247
    Event Type
    Injury
    Date Received
    March 28, 2019
    Report Date
    April 1, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (ANSM, REFERENCE NUMBER: R1906468) ON 26-MAR-2019. THE MOST RECENT INFORMATION WAS RECEIVED ON 01-APR-2019. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF BACK PAIN ("BACK PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 901336) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA, ABDOMINOPLASTY, BREAST PROSTHESIS IMPLANTATION IN (B)(6) 2012, TERMINATION OF PREGNANCY - ELECTIVE, MISCARRIAGE AND PARITY 2. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED BACK PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION ("ONLY RIGHT IMPLANT WAS VISIBLE, FOLLOWING A PROBABLE EXPULSION OF IMPLANT DURING MENSTRUATION"), PAIN IN EXTREMITY ("PAIN IN CALVES"), GAIT DISTURBANCE ("DIIFICULTIES TO MOVE"), DYSPNOEA ("SHORTNESS OF BREATH"), FATIGUE ("FATIGUE"), VISUAL IMPAIRMENT ("DECREASED VISION"), NAUSEA ("NAUSEA"), GROIN PAIN ("RIGHT AND LEFT PAIN IN GROIN"), MUSCLE SPASMS ("MUSCULAR CRAMPS") AND VOMITING ("VOMITING"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE BACK PAIN, PAIN IN EXTREMITY, GAIT DISTURBANCE, DYSPNOEA, NAUSEA, GROIN PAIN, MUSCLE SPASMS AND VOMITING WAS RESOLVING AND THE DEVICE EXPULSION, FATIGUE AND VISUAL IMPAIRMENT OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR BACK PAIN, DEVICE EXPULSION, DYSPNOEA, FATIGUE, GAIT DISTURBANCE, GROIN PAIN, MUSCLE SPASMS, NAUSEA, PAIN IN EXTREMITY, VISUAL IMPAIRMENT AND VOMITING WITH ESSURE. THE REPORTER COMMENTED: A FIRST INSERTION OF ESSURE WAS ON (B)(6) 2012, THEN AGAIN ON THE RIGHT SIDE ON (B)(6) 2012, FOLLOWING A PROBABLE EXPULSION OF IMPLANT DURING MENSTRUATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ABDOMINAL X-RAY - ON AN UNKNOWN DATE: ONLY RIGHT IMPLANT WAS VISIBLE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-APR-2019: QUALITY SAFETY EVALUATION OF PTC. 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Description of Event or Problem · 1

    THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY ((B)(6), REFERENCE NUMBER: (B)(4)) ON 26-MAR-2019. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF BACK PAIN ("BACK PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 901336) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA, ABDOMINOPLASTY, BREAST PROSTHESIS IMPLANTATION IN (B)(6) 2012, TERMINATION OF PREGNANCY - ELECTIVE, MISCARRIAGE AND PARITY 2. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED BACK PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION ("ONLY RIGHT IMPLANT WAS VISIBLE, FOLLOWING A PROBABLE EXPULSION OF IMPLANT DURING MENSTRUATION"), PAIN IN EXTREMITY ("PAIN IN CALVES"), GAIT DISTURBANCE ("DIFFICULTIES TO MOVE"), DYSPNOEA ("SHORTNESS OF BREATH"), FATIGUE ("FATIGUE"), VISUAL IMPAIRMENT ("DECREASED VISION"), NAUSEA ("NAUSEA"), GROIN PAIN ("RIGHT AND LEFT PAIN IN GROIN"), MUSCLE SPASMS ("MUSCULAR CRAMPS") AND VOMITING ("VOMITING"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE BACK PAIN, PAIN IN EXTREMITY, GAIT DISTURBANCE, DYSPNOEA, NAUSEA, GROIN PAIN, MUSCLE SPASMS AND VOMITING WAS RESOLVING AND THE DEVICE EXPULSION, FATIGUE AND VISUAL IMPAIRMENT OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR BACK PAIN, DEVICE EXPULSION, DYSPNOEA, FATIGUE, GAIT DISTURBANCE, GROIN PAIN, MUSCLE SPASMS, NAUSEA, PAIN IN EXTREMITY, VISUAL IMPAIRMENT AND VOMITING WITH ESSURE. THE REPORTER COMMENTED: A FIRST INSERTION OF ESSURE WAS ON (B)(6) 2012, THEN AGAIN ON THE RIGHT SIDE ON (B)(6) 2012, FOLLOWING A PROBABLE EXPULSION OF IMPLANT DURING MENSTRUATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ABDOMINAL X-RAY - ON AN UNKNOWN DATE: ONLY RIGHT IMPLANT WAS VISIBLE. 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253230 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 901336 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R