BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 8567682 · Received May 1, 2019

    Report

    Report Number
    2951250-2019-01563
    Event Type
    Injury
    Date Received
    May 1, 2019
    Report Date
    May 8, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE EXPULSION ("OTHER (LIST): EXPULSION / SHE PASSED AN ESSURE COIL WITH SOME OF THE CLOTS IN HER MENSES/ ONLY ONE TUBE WAS COMPLETELY BLOCKED") AND GENITAL HAEMORRHAGE ("BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 699886) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED GRAVIDA I, PARITY 1, RASH, ITCHING, SWELLING NOS, REDNESS, PSORIASIS, ALLERGY TO METALS, LOWER ABDOMINAL PAIN, VAGINAL BLEEDING, ADNEXAL MASS AND OVARIAN CYST. CONCURRENT CONDITIONS INCLUDED DYSLIPIDEMIA, DYSPHAGIA, GASTROINTESTINAL BLEEDING, KELOID SCAR, PROTEINURIA, ENDOCERVICITIS, SQUAMOUS CELL METAPLASIA, BENIGN POLYP OF UTERUS, ADENOMYOSIS, OVARIAN CYSTADENOFIBROMA, PERITONEAL CYST, FALLOPIAN TUBE CYST AND HYDROSALPINX. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PELVIC PAIN") AND DYSPAREUNIA ("DYSPAREUNIA"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL ABDOMINAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, GENITAL HAEMORRHAGE, PELVIC PAIN AND DYSPAREUNIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE EXPULSION, DYSPAREUNIA, GENITAL HAEMORRHAGE AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE COILS ARE IDENTIFIED FROM BOTH PLACES APPROXIMATELY 3. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: QUALITY SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT). INCIDENT: 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 NON-CONFORMANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, 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 DEVICE EXPULSION ("OTHER (LIST): EXPULSION / SHE PASSED AN ESSURE COIL WITH SOME OF THE CLOTS IN HER MENSES/ ONLY ONE TUBE WAS COMPLETELY BLOCKED") AND GENITAL HAEMORRHAGE ("BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 699886) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED GRAVIDA I, PARITY 1, RASH, ITCHING, SWELLING NOS, REDNESS, PSORIASIS, ALLERGY TO METALS, LOWER ABDOMINAL PAIN, VAGINAL BLEEDING, ADNEXAL MASS AND OVARIAN CYST. CONCURRENT CONDITIONS INCLUDED DYSLIPIDEMIA, DYSPHAGIA, GASTROINTESTINAL BLEEDING, KELOID SCAR, PROTEINURIA, ENDOCERVICITIS, SQUAMOUS CELL METAPLASIA, BENIGN POLYP OF UTERUS, ADENOMYOSIS, OVARIAN CYSTADENOFIBROMA, PERITONEAL CYST, FALLOPIAN TUBE CYST AND HYDROSALPINX. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PELVIC PAIN") AND DYSPAREUNIA ("DYSPAREUNIA"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL ABDOMINAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, GENITAL HAEMORRHAGE, PELVIC PAIN AND DYSPAREUNIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE EXPULSION, DYSPAREUNIA, GENITAL HAEMORRHAGE AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE COILS ARE IDENTIFIED FROM BOTH PLACES APPROXIMATELY 3. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN. INCIDENT 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363061 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 699886 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R