BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10191292 · Received June 24, 2020

    Report

    Report Number
    2951250-2020-09431
    Event Type
    Injury
    Date Received
    June 24, 2020
    Report Date
    January 29, 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 MEDICAL DEVICE REMOVAL ('REMOVAL'). IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ON (B)(6) 2010, 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 (REMOVAL OF ESSURE). 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 CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-JUL-2020, QSE FOR 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 PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 689939) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE HAEMORRHAGE ("ABNORMAL UTERINE BLEEDING"), ENDOMETRIOSIS ("ENDOMETRIOSIS") AND HAEMATOSALPINX ("HEMATOSALPINX"). THE PATIENT WAS TREATED WITH SURGERY (ROBOTICALLY ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ENDOMETRIOSIS, HAEMATOSALPINX, PELVIC PAIN AND UTERINE HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AT THE COMPLETION OF THE PROCEDURE THERE WERE 7 COILS ON THE LEFT AND 2 COILS ON THE RIGHT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PATHOLOGY TEST - ON (B)(6) 2019: A. UTERUS, CERVIX, BILATERAL FALLOPIAN TUBES, TOTAL HYSTERECTOMY BILATERAL SALPINGECTOMIES: UNREMARKABLE UTERINE CERVIX. PROLIFERATIVE ENDOMETRIUM. ADENOMYOSIS AND ADENOMYOMA. BILATERAL FALLOPIAN TUBES WITH ESSURE COILS. LOT NUMBER: 689939 MANUFACTURING DATE: 2009-11 EXPIRATION DATE: 2012-11. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 29-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 PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 689939) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE HAEMORRHAGE ("ABNORMAL UTERINE BLEEDING"), ENDOMETRIOSIS ("ENDOMETRIOSIS") AND HAEMATOSALPINX ("HEMATOSALPINX"). THE PATIENT WAS TREATED WITH SURGERY (ROBOTICALLY ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ENDOMETRIOSIS, HAEMATOSALPINX, PELVIC PAIN AND UTERINE HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AT THE COMPLETION OF THE PROCEDURE THERE WERE 7 COILS ON THE LEFT AND 2 COILS ON THE RIGHT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PATHOLOGY TEST - ON (B)(6) 2019: A. UTERUS, CERVIX, BILATERAL FALLOPIAN TUBES, TOTAL HYSTERECTOMY BILATERAL SALPINGECTOMIES: UNREMARKABLE UTERINE CERVIX. PROLIFERATIVE ENDOMETRIUM. ADENOMYOSIS AND ADENOMYOMA. BILATERAL FALLOPIAN TUBES WITH ESSURE COILS. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 25-JAN-2021: MR RECEIVED. LOT NO ADDED, PREVIOUSLY REPORTED EVENT "MEDICAL DEVICE REMOVAL" UPDATED TO " PELVIC PAIN¿. ESSURE DATE OF REMOVAL , REPORTER WAS ADDED. NON-DRUG TREATMENT NOTE UPDATED. NEW EVENT ADDED: ENDOMETRIOSIS, HAEMATOSALPINX AND UTERINE HAEMORRHAGE. 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 ('REMOVAL') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ON (B)(6) 2010, 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 (REMOVAL OF ESSURE). 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
    656443 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 689939 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R