BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9308256 · Received November 12, 2019

    Report

    Report Number
    2951250-2019-11396
    Event Type
    Injury
    Date Received
    November 12, 2019
    Date of Event
    February 1, 2011
    Report Date
    November 12, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ('MENORRHAGIA') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822366) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED STRESS URINARY INCONTINENCE AND MENORRHAGIA. CONCOMITANT PRODUCTS INCLUDED NSAIDS AND PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2011. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"), 21 DAYS AFTER INSERTION OF ESSURE. THE PATIENT WAS TREATED WITH SURGERY (THERMA CHOICE ENDOMETRIAL ABLATION). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE MENORRHAGIA, PELVIC PAIN, VAGINAL HAEMORRHAGE, 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: DISCREPANCY NOTED IN LAB TEST (HSG TEST). DISCREPANCY NOTED FOR INSERTION DATE:AS PER PFS INSERTION DATE (B)(6) 2011 AND AS PER MR 2011(THERMOCHOICE ABLATION DONE ON SAME DATE). DISCREPANCY NOTED. THE ESSURE DEVICE WAS PLACED INTO THE TUBAL OSTIA WITH FOUR COILS REMAINING ON THE RIGHT, THREE COILS REMAINING ON THE LEFT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM; ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: CASE BECAME INCIDENT. PFS RECEIVED SURGERY INFORMATION WAS ADDED. PATIENT INFORMATION WAS UPDATED. CONCOMITANT DRUG WAS ADDED. WE RECEIVED A LOT NUMBER. 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
    1105587 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 822366 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other| R