BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10390671 · Received August 11, 2020

    Report

    Report Number
    2951250-2020-13018
    Event Type
    Injury
    Date Received
    August 11, 2020
    Report Date
    August 11, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED ALLERGIC RHINITIS, DRUG HYPERSENSITIVITY (REACTION RASH SKIN )), PENICILLIN ALLERGY (REACTION RASH SKIN )), DRUG ALLERGY (REACTION RASH SKIN )), MENORRHAGIA AND ANESTHESIA. CONCOMITANT PRODUCTS INCLUDED ASCORBIC ACID; BETACAROTENE; CALCIUM CARBONATE; COLECALCIFEROL; DOCOSAHEXAENOIC ACID; FERROUS FUMARATE; FOLIC ACID; NICOTINAMIDE; PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE MONONITRATE; TOCOPHERYL ACETATE; VITAMIN B12 NOS; ZINC OXIDE (PRENATAL MULTIVITAMIN + DHA), DROSPIRENONE + ETHINYLESTRADIOL (YAZ) AND FLUOXETINE HYDROCHLORIDE (PROZAC). IN (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("MENORRHAGIA"), DYSMENORRHOEA ("DYSMENORRHEA") AND UTERINE PROLAPSE ("UTERINE PROLAPSE"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL VAGINAL HYSTERECTOMY AND BILATERAL SALPINGECTOMIES). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSMENORRHOEA, MENORRHAGIA, PELVIC PAIN AND UTERINE PROLAPSE TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-JUL-2020: PLAINTIFF FACT SHEET RECEIVED , PATIENT CONCOMITANT CONDITION,MEDIATION, EVENT INJURY TO HERSELF DELETED , NEW EVENT PELVIC PAIN,ESSURE REMOVAL INFORMATION 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
    854600 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R PRENATAL MULTIVITAMIN + DHA| PROZAC| YAZ