BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSURE

    MDR report key: 10285634 · Received July 16, 2020

    Report

    Report Number
    2951250-2020-11579
    Event Type
    Malfunction
    Date Received
    July 16, 2020
    Report Date
    August 17, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Product Problem
    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 DEVICE BREAKAGE ('ESSURE IS BROKEN INSIDE HER FALLOPIAN TUBE') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893037) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED ROTATOR CUFF REPAIR IN (B)(6) 2014, BREAST BIOPSY IN (B)(6) 2010, DYSMENORRHEA, ENDOMETRIOSIS, KIDNEY STONES, CHRONIC URTICARIA, ALLERGIC REACTION TO ANALGESICS, DRUG HYPERSENSITIVITY AND ANAPHYLACTIC REACTION TO DRUG. CONCOMITANT PRODUCTS INCLUDED CALCIUM CARBONATE;FAMOTIDINE;MAGNESIUM HYDROXIDE (PEPCID COMPLETE), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) AND OMALIZUMAB (XOLAIR). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("DYSMENORRHEA") AND DEVICE DISLOCATION ("MIGRATION "). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DYSMENORRHOEA AND DEVICE DISLOCATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE BREAKAGE, DEVICE DISLOCATION AND DYSMENORRHOEA TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: ESSURE PLACEMENT. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-AUG-2020: QUALITY-SAFETY EVALUATION OF PTC WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS 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 DEVICE BREAKAGE ('ESSURE IS BROKEN INSIDE HER FALLOPIAN TUBE') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893037) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED SHOULDER OPERATION IN (B)(6) 2014, BREAST BIOPSY IN (B)(6) 2010, DYSMENORRHEA, ENDOMETRIOSIS, KIDNEY STONES, CHRONIC URTICARIA, DRUG HYPERSENSITIVITY, DRUG HYPERSENSITIVITY AND DRUG HYPERSENSITIVITY. CONCOMITANT PRODUCTS INCLUDED CALCIUM CARBONATE;FAMOTIDINE;MAGNESIUM HYDROXIDE (PEPCID COMPLETE), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) AND OMALIZUMAB (XOLAIR). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("DYSMENORRHEA") AND DEVICE DISLOCATION ("MIGRATION "). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DYSMENORRHOEA AND DEVICE DISLOCATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE BREAKAGE, DEVICE DISLOCATION AND DYSMENORRHOEA TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: ESSURE PLACEMENT. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. 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
    745329 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 893037 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other PEPCID COMPLETE| PEPCID COMPLETE| XOLAIR| XOLAIR| ZYRTEC ALLERGY| ZYRTEC ALLERGY