BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3955139 · Received July 10, 2014

    Report

    Report Number
    2951250-2014-00271
    Event Type
    Injury
    Date Received
    July 10, 2014
    Report Date
    July 10, 2014
    Manufacturer
    BAYER HEALTHCARE
    Product Code
    HHS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP (B)(4) 2014: PTC INVESTIGATION RESULTS WERE PROVIDED. FINAL ASSESSMENT: SINCE NO PRODUCT WAS RETURNED TO US FOR INVESTIGATION, WE WERE UNABLE TO PERFORM AN INVESTIGATION OF THE ACTUAL DEVICE INVOLVED IN THIS COMPLAINT. TYPICALLY, WE WOULD INSPECT THE MICRO-INSERT TO CONFIRM THAT ALL PARTS ARE ACCOUNTED FOR AND INSPECT THE DEVICE TO LOOK FOR ANY MANUFACTURING DEFICIENCIES. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT AT THIS TIME. FINAL RISK CLASSIFICATION: RISK CATEGORY IV. MEDICAL ASSESSMENT: THE MEDICAL EVENTS REPORTED ARE NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT. NO COMPLAINT SAMPLE WAS PROVIDED FOR A TECHNICAL INVESTIGATION. NO BATCH NUMBER WAS REPORTED. NEITHER A TECHNICAL BATCH INVESTIGATION NOR A BATCH CLUSTER REVIEW IN THE (B)(4) DATABASE FOR A MORE DETAILED STATISTICAL MEDICAL EVALUATION IS POSSIBLE WITHOUT A BATCH NUMBER. AT THE TIME OF THIS MEDICAL ASSESSMENT THE TECHNICAL INVESTIGATION CONCLUDED "UNCONFIRMED QUALITY DEFECT". BASED ON THE INFORMATION AVAILABLE, THERE IS NO REASON TO SUSPECT A QUALITY DEFECT. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED, SOLICITED CASE REPORT, WAS RECEIVED FROM A FEMALE CONSUMER THROUGH (B)(4) AND REFERS TO A (B)(6) WHO HAD ESSURE MICRO-INSERT EXPOSURE IN UTERO AND WAS BORN AT (B)(6). BORN AT (B)(6) WAS CONSIDERED SERIOUS AS MEDICALLY SIGNIFICANT AND IT IS UNLISTED ACCORDING TO THE REFERENCE SAFETY INFORMATION FOR ESSURE. THIS EVENT WAS CONSIDERED AN INCIDENT AS IT COULD HAVE LED TO SERIOUS DETERIORATION OF THE (B)(6) HEALTH. PRE TERM LABOR PRECEDES ALMOST HALF OF PRETERM BIRTHS (LESS THAN 37 WEEKS GESTATION) AND IT IS A CAUSE OF NEONATAL MORTALITY. ITS EXACT MECHANISMS ARE UNKNOWN BUT ARE BELIEVED TO INCLUDE: DECIDUAL HEMORRHAGE, CERVICAL INCOMPETENCE, HORMONAL CHANGES, UTERINE DISTORTION AND CERVICAL OR MATERNAL INFLAMMATION. IN THIS PARTICULAR CASE, GIVEN THE GESTATIONAL AGE AT BIRTH A MECHANICAL INTERFERENCE BETWEEN ESSURE AND THE DEVELOPING PREGNANCY CANNOT BE EXCLUDED AND THE REPORTED EVENT WAS, THEREFORE CONSIDERED AS RELATED TO THE SUSPECT INSERT. A PRODUCT TECHNICAL COMPLAINT (PTC) ANALYSIS WAS PERFORMED AND CONCLUDED THAT BASED ON THE INFORMATION AVAILABLE, THERE IS NO REASON TO SUSPECT A QUALITY DEFECT OF THE PRODUCT.

    Description of Event or Problem · 1

    THIS SOLICITED CASE REPORT WAS RECEIVED FROM A CONSUMER IN THE UNITED STATES ON (B)(4) 2014 VIA (B)(4). THE REPORT REFERS TO REPORTER'S BABY, (B)(6) . IT WAS REPORTED THAT THE REPORTING CONSUMER HAD ESSURE INSERTED FOR BIRTH CONTROL AND IT FAILED. THE CONSUMER HAS A (B)(6). NO FURTHER IN FORMATION WAS PROVIDED. (B)(4). FOLLOW UP INFORMATION FROM (B)(4) 2014: NO FURTHER FOLLOW UP WILL BE ATTEMPTED FOR THIS CASE .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404400 ESSURE DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE HHS BAYER HEALTHCARE ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1