BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 5275166 · Received December 8, 2015

    Report

    Report Number
    2951250-2015-01895
    Event Type
    Injury
    Date Received
    December 8, 2015
    Report Date
    January 20, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP RECEIVED ON 29-FEB-2016: DESPITE OF FOLLOW-UP ATTEMPTS, NO RESPONSE WAS RECEIVED TO DATE. CASE CONSIDERED TO BE CLOSED. COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT REFERS TO A FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND PRESENTED PELVIC PAIN. THIS EVENT IS SERIOUS DUE TO MEDICAL IMPORTANCE AND LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. PELVIC PAIN MAY OCCUR DURING ESSURE USE. IN THIS CASE VERY LIMITED INFORMATION WAS PROVIDED. IT WAS ONLY REPORTED THAT ESSURE WAS BEING REMOVED AND THE PATIENT HAD PELVIC PAIN. BASED ON AVAILABLE INFORMATION AND EVENT'S NATURE, CAUSALITY WITH SUSPECT INSERT CANNOT BE EXCLUDED AND SINCE DEVICE REMOVAL WAS REQUIRED, THIS CASE IS REGARDED AS INCIDENT. ACCORDING TO PRODUCT TECHNICAL ANALYSIS, THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENT (S) AND A QUALITY DEFECT.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PTC INVESTIGATION RESULT WAS RECEIVED ON 04-JAN-2016. THIS ADVERSE EVENT REPORT IS RELATED TO A PRODUCT TECHNICAL COMPLAINT (PTC). THE BAYER REFERENCE NUMBER FOR THE PTC REPORT IS: PTC GLOBAL NUMBER (B)(4). FINAL ASSESSMENT: FOR CASES WHERE A DEVICE FAILURE DURING INSERTION IS REPORTED, WE CONDUCT AN INVESTIGATION OF ANY RETURNED DEVICE. FOR CASES WHERE AN INSERT IS REMOVED AT A LATER TIME AFTER INSERTION, WE TYPICALLY DO NOT CONDUCT AN INSPECTION OF THE INSERT. IN THIS CASE, NO PRODUCT WAS RETURNED. 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. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. MEDICAL ASSESSMENT: BASED ON THE AVAILABLE INFORMATION NO PRODUCT QUALITY DEFECT WAS CONFIRMED. THE REPORTED MEDICAL EVENT(S) IS A KNOWN POSSIBLE UNDESIRABLE EVENT AND NOT INDICATIVE OF A QUALITY DEFICIT PER SE. SINCE NO BATCH NUMBER WAS REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES IS NOT APPLICABLE. IN SUMMARY, THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENT (S) AND A QUALITY DEFECT. COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT REFERS TO A FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND PRESENTED PELVIC PAIN. THIS EVENT IS SERIOUS DUE TO MEDICAL IMPORTANCE AND LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. PELVIC PAIN MAY OCCUR DURING ESSURE USE. IN THIS CASE VERY LIMITED INFORMATION WAS PROVIDED. IT WAS ONLY REPORTED THAT ESSURE WAS BEING REMOVED AND THE PATIENT HAD PELVIC PAIN. BASED ON AVAILABLE INFORMATION AND EVENT'S NATURE, CAUSALITY WITH SUSPECT INSERT CANNOT BE EXCLUDED AND SINCE DEVICE REMOVAL WAS REQUIRED, THIS CASE IS REGARDED AS INCIDENT. ACCORDING TO PRODUCT TECHNICAL ANALYSIS, THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENT (S) AND A QUALITY DEFECT. FURTHER INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A PHYSICIAN VIA SALES CONSULTANT IN UNITED STATES ON 13-NOV-2015 WHICH REFERS TO A FEMALE PATIENT OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED. BAYER SALES CONSULTANT WAS CALLED TO GOT TO THE HOSPITAL AND IT WAS NOT AN ESSURE INSERTION BUT A REMOVAL OF ESSURE. PATIENT HAD BEEN COMPLAINING OF PELVIC PAIN. SHE DID NOT ATTEND IN REMOVAL PROCEDURE. SALES CONSULTANT WAS UNSURE ABOUT ESSURE REMOVAL. COMPANY CAUSALITY COMMENT THIS MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT REFERS TO A FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND PRESENTED PELVIC PAIN. THIS EVENT IS SERIOUS DUE TO MEDICAL IMPORTANCE AND LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. PELVIC PAIN MAY OCCUR DURING ESSURE USE. IN THIS CASE VERY LIMITED INFORMATION WAS PROVIDED. IT WAS ONLY REPORTED THAT ESSURE WAS BEING REMOVED AND THE PATIENT HAD PELVIC PAIN. BASED ON AVAILABLE INFORMATION AND EVENT'S NATURE, CAUSALITY WITH SUSPECT INSERT CANNOT BE EXCLUDED AND SINCE DEVICE REMOVAL WAS REQUIRED, THIS CASE IS REGARDED AS INCIDENT. FURTHER INFORMATION AND TECHNICAL ASSESSMENT HAVE BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803384 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R