BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10187306 · Received June 24, 2020

    Report

    Report Number
    2951250-2020-09318
    Event Type
    Injury
    Date Received
    June 24, 2020
    Report Date
    May 25, 2021
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABNORMAL UTERINE BLEEDING ('ABNORMAL UTERINE BLEEDING') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882183) INSERTED FOR FEMALE STERILISATION. THE PATIENT'S MEDICAL HISTORY INCLUDED CERVICITIS, ADENOMYOSIS AND UTERINE LEIOMYOMA. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABNORMAL UTERINE BLEEDING (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVED/VAGINAL HYSTERECTOMY, SALPINGECTOMY COMPLETE). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE ABNORMAL UTERINE BLEEDING OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABNORMAL UTERINE BLEEDING TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DATE(S) OF INSERTION: (B)(6) 2012 (AS PER MR, DISCREPANCY NOTED) 2 TRAILING COIL(S) WERE NOTED ON THE RIGHT SIDE AND 5 TRAILING COIL(S) WERE NOTED ON THE LEFT SIDE FOLLOWING IMPLANTATION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDIA RECORDS: ABNORMAL UTERINE BLEEDING. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-MAY-2021: MR RECEIVED. REPORTER INFORMATION , PATIENT DETAILS , STOP DATE , LOT NUMBER, OTHER RELEVANT HISTORY ADDED . EVENT : " ESSURE REMOVED " UPDATED TO " ABNORMAL UTERINE BLEEDING" AND RCC WAS UPDATED. 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.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER, AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('ESSURE REMOVED'). IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVED). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-JUL-2020, QUALITY SAFETY EVALUATION OF PTC. BASED ON THE AVAILABLE INFORMATION. A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED. ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION, WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABNORMAL UTERINE BLEEDING ('ABNORMAL UTERINE BLEEDING') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882183) INSERTED FOR FEMALE STERILISATION. THE PATIENT'S MEDICAL HISTORY INCLUDED CERVICITIS, ADENOMYOSIS AND UTERINE LEIOMYOMA. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABNORMAL UTERINE BLEEDING (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVED/VAGINAL HYSTERECTOMY, SALPINGECTOMY COMPLETE). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE ABNORMAL UTERINE BLEEDING OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABNORMAL UTERINE BLEEDING TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DATE(S) OF INSERTION: (B)(6) 2012 (AS PER MR, DISCREPANCY NOTED) 2 TRAILING COIL(S) WERE NOTED ON THE RIGHT SIDE AND 5 TRAILING COIL(S) WERE NOTED ON THE LEFT SIDE FOLLOWING IMPLANTATION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDIA RECORDS: ABNORMAL UTERINE BLEEDING. LOT NUMBER: 882183 MANUFACTURING DATE: 2011-07 EXPIRATION DATE: 2014-07 . 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 21-MAY-2021: QUALITY SAFETY EVALUATION OF PTC. 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.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('ESSURE REMOVED') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVED). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657147 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 882183 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R