BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10097636 · Received May 28, 2020

    Report

    Report Number
    2951250-2020-08162
    Event Type
    Injury
    Date Received
    May 28, 2020
    Date of Event
    February 1, 2014
    Report Date
    May 28, 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

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN') IN A (B)(6) YEAR OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 854114-INV) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED DEPRESSION, ASTHMA, RHEUMATOID ARTHRITIS, HEADACHE, VAGINAL IRRITATION, VAGINAL ODOUR, MOUTH ULCERATION, ALLERGIC RHINITIS, BIPOLAR DISORDER, AMENORRHEA, ANEMIA, ABSCESS ON BUTTOCK, NON-CARDIAC CHEST PAIN AND OVARIAN CYST. SHE DENIES ASSOCIATED VAGINAL ITCHING, DYSPAREUNIA, FEVER, ABDOMINAL PAIN OR PELVIC PAIN. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO PROVERA FROM (B)(6) 2013 TO (B)(6) 2014, MIRENA FROM (B)(6) 2013 TO (B)(6) 2013 AND NSAIDS. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA), NSAIDS SINCE (B)(6) 2014 AND PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2014. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("MENORRHAGIA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION/ PSYCH INJURY") AND ANXIETY ("MENTAL ANGUISH"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY, UNILATERAL, REMOVAL OF COIL). AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE DEVICE WAS COMPLETED, THE DEVICE FIRED AND SEATED, WITH 2 VISIBLE RINGS ON THE RIGHT AND 1 VISIBLE RINGS ON THE LEFT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM ON (B)(6) 2014: TOTAL BILATERAL OCCLUSION. PREGNANCY TEST ON AN UNKNOWN DATE: NEGATIVE. LOT NUMBER (854114) IS INVALID. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-MAY-2020: UPDATE OF INFORMATION (BATCH IS INVALID). 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 RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561289 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 854114-INV 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other| R