BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10732650 · Received October 26, 2020

    Report

    Report Number
    2951250-2020-15307
    Event Type
    Injury
    Date Received
    October 26, 2020
    Report Date
    January 11, 2021
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF GENITAL HAEMORRHAGE ('HEAVY BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882184) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABDOMINAL DISCOMFORT ("DISCOMFORT IN ABDOMEN"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC BILATERAL SALPINGECTOMY. LAPAROSCOPIC BILATERAL UTERINE CORNUECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE AND ABDOMINAL DISCOMFORT OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISCOMFORT AND GENITAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: (B)(6) 2011 (PER MR): ESSURE INSERTION DATE: THE NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY WAS 3.THE IDENTICAL STEPS WERE UNDERTAKEN TO INSERT THE ESSURE MICRO-INSERT IN THE OPPOSITE TUBE. THE NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY WAS 3.5HE TOLERATED THE PROCEDURE WELL, STATING. (B)(6) 2019 (PER MR): LAPAROSCOPIC BILATERAL SALPINGECTOMY. LAPAROSCOPIC BILATERAL UTERINE CORNUECTOMY . (B)(6) 2019 (PER MR): TOTAL LAPAROSCOPIC HYSTERECTOMY. LYSIS OF ADHESIONS. CYSTOSCOPY. SURGICAL PATHOLOGY REPORT: UTERUS, CERVIX: BENIGN ECTOCERVICAL AND ENDOCERVICAL TISSUE. SOME BENIGN ENDOMETRIAL TISSUE WITH ASSOCIATED FIBROSIS. BENIGN INTRAMURAL LEIOMYOMA (UTERUS).COMMENT: THE ASSOCIATED FIBROSIS MAY REPRESENT PRIOR THERAPEUTIC/ABLATIVE-TYPE CHANGES. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-JAN-2021: QUALITY SAFETY EVALUATION OF PTC. 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.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF GENITAL HAEMORRHAGE ('HEAVY BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABDOMINAL DISCOMFORT ("DISCOMFORT IN ABDOMEN"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE AND ABDOMINAL DISCOMFORT OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISCOMFORT AND GENITAL HAEMORRHAGE TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 29-OCT-2020: QUALITY-SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL 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.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF GENITAL HAEMORRHAGE ('HEAVY BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882184) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABDOMINAL DISCOMFORT ("DISCOMFORT IN ABDOMEN"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC BILATERAL SALPINGECTOMY. LAPAROSCOPIC BILATERAL UTERINE CORNUECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE AND ABDOMINAL DISCOMFORT OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISCOMFORT AND GENITAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: (B)(6) 2011 (PER MR): ESSURE INSERTION DATE: THE NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY WAS 3.THE IDENTICAL STEPS WERE UNDERTAKEN TO INSERT THE ESSURE MICRO-INSERT IN THE OPPOSITE TUBE. THE NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY WAS 3.5HE TOLERATED THE PROCEDURE WELL, STATING. (B)(6) 2019 (PER MR): LAPAROSCOPIC BILATERAL SALPINGECTOMY. LAPAROSCOPIC BILATERAL UTERINE CORNUECTOMY . (B)(6) 2019 (PER MR): TOTAL LAPAROSCOPIC HYSTERECTOMY. LYSIS OF ADHESIONS. CYSTOSCOPY. SURGICAL PATHOLOGY REPORT: UTERUS, CERVIX: BENIGN ECTOCERVICAL AND ENDOCERVICAL TISSUE. SOME BENIGN ENDOMETRIAL TISSUE WITH ASSOCIATED FIBROSIS. BENIGN INTRAMURAL LEIOMYOMA (UTERUS).COMMENT: THE ASSOCIATED FIBROSIS MAY REPRESENT PRIOR THERAPEUTIC/ABLATIVE-TYPE CHANGES. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-JAN-2021: MEDICAL RECORD RECEIVED. ESSURE LOT NUMBER WAS ADDED. THIS CASE WAS MEDICALLY CONFIRMED. PATIENT DEMOGRAPHICS, ESSURE INSERTION/REMOVAL DATE (UPDATED) AND REPORTERS 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.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF GENITAL HAEMORRHAGE ('HEAVY BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABDOMINAL DISCOMFORT ("DISCOMFORT IN ABDOMEN"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE AND ABDOMINAL DISCOMFORT OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISCOMFORT AND GENITAL HAEMORRHAGE 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
    1197696 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 882184 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R