BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 11821121 · Received May 13, 2021

    Report

    Report Number
    2951250-2021-02151
    Event Type
    Injury
    Date Received
    May 13, 2021
    Report Date
    May 24, 2021
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    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 PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY: BIRTH - NO COMPLICATION') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 852005) 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 "ESSURE CONFIRMATION TEST(S) CONDUCTED, SPECIFY NO" AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED TUBAL LIGATION ON (B)(6) 2014 AND MULTIPAROUS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("GENERAL ABNORMAL BLEEDING"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS") AND PSYCHOLOGICAL TRAUMA ("PSYCH INJURY") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, PREGNANCY WITH CONTRACEPTIVE DEVICE, FATIGUE, ALOPECIA AND PSYCHOLOGICAL TRAUMA OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST, SECOND AND THIRD TRIMESTERS. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH. IT WAS UNKNOWN WHETHER THE CHILD WAS HEALTHY. THE REPORTER CONSIDERED ALOPECIA, FATIGUE, GENITAL HAEMORRHAGE, PREGNANCY WITH CONTRACEPTIVE DEVICE AND PSYCHOLOGICAL TRAUMA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ADDITIONAL SURGERIES: TUBAL LIGATION WAS DONE ON (B)(6) 2014. RECORDS IN ATTY POSSESSION- IMPLANT, CONFIRM TEST. PATIENT HAD MORE THAN ONE ESSURE RELATED SURGERY ON (B)(6) 2014. IN THE LEFT SIDE, THE COIL EXPOSED WAS SIX COIL; AND ON THE RIGHT SIDE, THE COIL EXPOSED WAS ONE COIL. AS PER MR, DISCREPANCY NOTED IN DATE OF INSERTION: (B)(6) 2014 LOT NUMBER: 852005 MANUFACTURING DATE: 2011-04, EXPIRATION DATE: 2014-04. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2021: QUALITY SAFETY EVALUATION OF PTC(PRODUCT TECHNICAL COMPLAINT). 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 PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY: BIRTH - NO COMPLICATION') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 852005) 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 "ESSURE CONFIRMATION TEST(S) CONDUCTED, SPECIFY NO" AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED TUBAL LIGATION ON (B)(6) 2014 AND MULTIPAROUS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("GENERAL ABNORMAL BLEEDING"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS") AND PSYCHOLOGICAL TRAUMA ("PSYCH INJURY") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, PREGNANCY WITH CONTRACEPTIVE DEVICE, FATIGUE, ALOPECIA AND PSYCHOLOGICAL TRAUMA OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST, SECOND AND THIRD TRIMESTERS. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH. IT WAS UNKNOWN WHETHER THE CHILD WAS HEALTHY. THE REPORTER CONSIDERED ALOPECIA, FATIGUE, GENITAL HAEMORRHAGE, PREGNANCY WITH CONTRACEPTIVE DEVICE AND PSYCHOLOGICAL TRAUMA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ADDITIONAL SURGERIES: TUBAL LIGATION WAS DONE ON (B)(6) 2014. RECORDS IN ATTY POSSESSION- IMPLANT, CONFIRM TEST. PATIENT HAD MORE THAN ONE ESSURE RELATED SURGERY ON (B)(6) 2014. IN THE LEFT SIDE, THE COIL EXPOSED WAS SIX COIL; AND ON THE RIGHT SIDE, THE COIL EXPOSED WAS ONE COIL. AS PER MR, DISCREPANCY NOTED IN DATE OF INSERTION: (B)(6) 2014. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 29-APR-2021: MR RECEIVED. REPORTER INFORMATION, PATIENT'S RACE INFORMATION, MEDICAL HISTORY, LOT NUMBER AND RCC 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713537 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 852005 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other