BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4192845 · Received October 22, 2014

    Report

    Report Number
    2951250-2014-00454
    Event Type
    Injury
    Date Received
    October 22, 2014
    Report Date
    January 19, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATA CORRECTION FOR US REPORTING: THE CODE KNH WAS REPLACED WITH HHS.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP FROM 27-MAR-2015: THE REQUIRED NUMBER OF FOLLOW-UP ATTEMPTS HAS BEEN COMPLETED, WITH NO RESPONSE TO DATE. NO FURTHER FOLLOW-UP WILL BE PURSUED. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED SEVERE BACK PAIN AND EXCESSIVE BLEEDING. BOTH EVENTS ARE SERIOUS DUE MEDICAL IMPORTANCE AND LISTED IN THE ESSURE REFERENCE SAFETY INFORMATION. BLEEDING AND PAIN MAY OCCUR WITH ESSURE USE. CONSIDERING LACK OF PLAUSIBLE ALTERNATIVE EXPLANATION AND POSITIVE TEMPORAL RELATIONSHIP, CAUSALITY CANNOT BE EXCLUDED. HYSTERECTOMY WAS REPORTED HENCE THIS CASE IS REGARDED AS INCIDENT. A PRODUCT TECHNICAL COMPLAINT (PTC) ANALYSIS WAS PERFORMED AND CONCLUDED TO AN UNCONFIRMED QUALITY DEFECT. MEDICAL PTC ASSESSMENT CONSIDERED THAT, BASED ON THE AVAILABLE INFORMATION, THERE IS NO REASON TO SUSPECT QUALITY DEFECT OF THE PRODUCT.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A CONSUMER VIA REGULATORY AUTHORITY (CASE MW5037347) IN UNITED STATES ON (B)(6)-2014 WHICH REFERS TO HERSELF WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED ON AN UNSPECIFIED DATE. AFTER SHE HAD THE ESSURE PROCEDURE, SHE EXPERIENCED SEVERE BACK PAIN FOLLOWED BY PHYSICIAN'S VISITS, CORTISONE SHOTS, MRI'S (MAGNETIC RESSONANCE IMAGES) AND THERAPY (NOT SPECIFIED). SHE ALSO EXPERIENCED BAD MIGRAINES, CRAMPING, EXCESSIVE BLEEDING, PELVIC PAIN, HAIR LOSS, WEIGHT GAIN, BRAIN FOG, BLOATING, AND IRRITABLE. ESSURE WAS REMOVED ON (B)(6)-2014 VIA HYSTERECTOMY. FOLLOW-UP RECEIVED ON 07-OCT-2014. PRODUCT TECHNICAL COMPLAINT INVESTIGATION AND FINAL ASSESSMENT WERE RECEIVED: THIS ADVERSE EVENT REPORT IS RELATED TO A PRODUCT TECHNICAL COMPLAINT (REQUEST FOR CONFIRMATION OF QUALITY). (B)(4). 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 OR DEVICE MALFUNCTION AT THIS TIME. MEDICAL ASSESSMENT: THIS PTC WAS INITIATED DUE TO A REQUEST FOR CONFIRMATION OF QUALITY. THE REPORTED ADVERSE EVENTS CONSIDERED RELATED ARE KNOWN POSSIBLE UNDESIRABLE EVENTS AND NOT INDICATIVE OF A QUALITY DEFECT PER SE. NO BATCH NUMBER WAS REPORTED. WITHOUT THIS INFORMATION NO BATCH SIGNAL CLUSTER REVIEW IN THE (B)(6) DATABASE FOR A MORE DETAILED STATISTICAL MEDICAL EVALUATION IS POSSIBLE. NO COMPLAINT SAMPLE WAS PROVIDED FOR FURTHER TECHNICAL INVESTIGATION. THE TECHNICAL ASSESSMENT CONCLUDED UNCONFIRMED QUALITY DEFECT. IN SUMMARY, THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT BASED ON THIS REPORT. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED SEVERE BACK PAIN AND EXCESSIVE BLEEDING. BOTH EVENTS ARE SERIOUS DUE MEDICAL IMPORTANCE AND LISTED IN THE ESSURE REFERENCE SAFETY INFORMATION. BLEEDING AND PAIN MAY OCCUR WITH ESSURE USE. CONSIDERING LACK OF PLAUSIBLE ALTERNATIVE EXPLANATION AND POSITIVE TEMPORAL RELATIONSHIP, CAUSALITY CANNOT BE EXCLUDED. HYSTERECTOMY WAS REPORTED HENCE THIS CASE IS REGARDED AS INCIDENT. A PRODUCT TECHNICAL COMPLAINT (PTC) ANALYSIS WAS PERFORMED AND CONCLUDED TO AN UNCONFIRMED QUALITY DEFECT. MEDICAL PTC ASSESSMENT CONSIDERED THAT, BASED ON THE AVAILABLE INFORMATION, THERE IS NO REASON TO SUSPECT QUALITY DEFECT OF THE PRODUCT. ADDITIONAL INFORMATION FROM CONSUMER WERE REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673514 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R