BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10120077 · Received June 4, 2020

    Report

    Report Number
    2951250-2020-08338
    Event Type
    Injury
    Date Received
    June 4, 2020
    Report Date
    June 18, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 940969) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST.". ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), AUTOIMMUNE DISORDER ("AUTOIMMUNE DISORDER NOS"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS"), TOOTH DISORDER ("DENTAL PROBLEMS"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"), FATIGUE ("FATIGUE,"), MIGRAINE ("MIGRAINE HEADACHE"), ALLERGY TO METALS ("NICKEL ALLERGY"), PSORIASIS ("RASHES OR SKIN CONDITIONS TYPE: PSORIASIS"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), ALOPECIA ("HAIR LOSS"), SKIN INFECTION ("SKIN INFECTION AND SUBCUTANEOUS INFECTION"), NAUSEA ("NAUSEA"), VULVOVAGINAL PAIN ("VAGINAL PAIN") AND DERMATITIS ("SKIN INFLAMMATION NOS") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES") AND WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE PELVIC PAIN, HORMONE LEVEL ABNORMAL, AUTOIMMUNE DISORDER, BLADDER DISORDER, URINARY TRACT DISORDER, TOOTH DISORDER, DYSMENORRHOEA, FATIGUE, MIGRAINE, ALLERGY TO METALS, PSORIASIS, VAGINAL DISCHARGE, WEIGHT INCREASED, ALOPECIA, SKIN INFECTION, VULVOVAGINAL PAIN AND DERMATITIS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALLERGY TO METALS, ALOPECIA, AUTOIMMUNE DISORDER, BLADDER DISORDER, DERMATITIS, DYSMENORRHOEA, FATIGUE, HORMONE LEVEL ABNORMAL, MIGRAINE, NAUSEA, PELVIC PAIN, PSORIASIS, SKIN INFECTION, TOOTH DISORDER, URINARY TRACT DISORDER, VAGINAL DISCHARGE, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: MOST OF IT SYMPTOMS WERE DECREASED. CURRENT WEIGHT 138 LBS. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-JUN-2020: PFS RECEIVED. REPORTER'S INFORMATION ADDED. LOT NO. WERE ADDED.EVENTS: MEDICAL DEVICE REMOVAL WERE UPDATE D TO VAGINAL PAIN. NEW EVENTS: HORMONAL CHANGES, AUTOIMMUNE DISORDER, BLADDER OR URINARY PROBLEMS OR CHANGES, DENTAL PROBLEMS, DYSMENORRHEA (CRAMPING), FATIGUE, MIGRAINES /HEADACHES, NICKEL ALLERGY, RASHES OR SKIN CONDITIONS TYPE: PSORIASIS, VAGINAL DISCHARGE, WEIGHT GAIN, HAIR LOSS, SKIN INFECTION, SKIN INFLAMMATION, SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST, PELVIC PAIN WERE ADDED. 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.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('MEDICAL DEVICE REMOVAL') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (TO ESSURE REMOVAL). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PFS RECEIVED. CLUSTER ID ADDED, EVENT INJURY NOS REPLACE WITH NEW EVENT MEDICAL DEVICE REMOVAL. 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
    584493 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 940969 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R