BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10013050 · Received April 30, 2020

    Report

    Report Number
    2951250-2020-06239
    Event Type
    Injury
    Date Received
    April 30, 2020
    Report Date
    May 5, 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 MEDICAL DEVICE REMOVAL ('OVARIES REMOVED') 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: MEDICAL DEVICE MONITORING ERROR "I HAD A UTERINE ABLATION DONE WHEN ESSURE IMPLANTS WERE PLACED" IN (B)(6)2014. THE PATIENT'S MEDICAL HISTORY INCLUDED MUSCLE CRAMPS. IN (B)(6)2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND EXPERIENCED HYPOMENORRHOEA ("I HAVE A LIGHT SPOTTING PERIOD EVERY MONTH"), ABDOMINAL PAIN ("CRAMPING"), ALOPECIA ("I HAVE THICK HAIR BUT LITERALLY CLUMPS AND CLUMPS COME OUT EVERY TIME I WASH OR EVEN COMB MY HAIR") AND STRESS ("I WAS THINKING IT WAS STRESS UNTIL I READ THIS POST"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL, HYPOMENORRHOEA, ABDOMINAL PAIN, ALOPECIA AND STRESS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, HYPOMENORRHOEA, MEDICAL DEVICE REMOVAL AND STRESS TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 30-APR-2020: QUALITY SAFETY EVALUATION OF PTC. 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 ('OVARIES REMOVED') 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: MEDICAL DEVICE MONITORING ERROR "I HAD A UTERINE ABLATION DONE WHEN ESSURE IMPLANTS WERE PLACED" IN (B)(6) 2014. THE PATIENT'S MEDICAL HISTORY INCLUDED MUSCLE CRAMPS. IN (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND EXPERIENCED HYPOMENORRHOEA ("I HAVE A LIGHT SPOTTING PERIOD EVERY MONTH"), ABDOMINAL PAIN ("CRAMPRING"), ALOPECIA ("I HAVE THICK HAIR BUT LITERALLY CLUMPS AND CLUMPS COME OUT EVERY TIME I WASH OR EVEN COMB MY HAIR") AND STRESS ("I WAS THINKING IT WAS STRESS UNTIL I READ THIS POST"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL, HYPOMENORRHOEA, ABDOMINAL PAIN, ALOPECIA AND STRESS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, HYPOMENORRHOEA, MEDICAL DEVICE REMOVAL AND STRESS TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-MAR-2020: SOCIAL MEDIA PROCESSED. CASE WAS MADE SERIOUS INCIDENT. EVENT MEDICAL DEVICE REMOVAL 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478576 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R