BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7056608 · Received November 23, 2017

    Report

    Report Number
    2951250-2017-08400
    Event Type
    Injury
    Date Received
    November 23, 2017
    Report Date
    August 17, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    E WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FDA, REFERENCE NUMBER: MW5072823) ON 27-OCT-2017. THE MOST RECENT INFORMATION WAS RECEIVED ON 14-AUG-2018. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT THIS SPONTANEOUS CASE WAS REPORTED BY A PHARMACIST AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("CHRONIC PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922613) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON(B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), NAUSEA ("NAUSEA") AND WEIGHT DECREASED ("WEIGHT LOSS"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL FALLOPIAN TUBE/ESSURE REMOVAL PERFORMED). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, NAUSEA AND WEIGHT DECREASED OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL PAIN, NAUSEA, PELVIC PAIN AND WEIGHT DECREASED WITH ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-AUG-2018: QUALITY SAFETY EVALUATION OF PTC. INCIDENT AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FDA, REFERENCE NUMBER: MW5072823) ON 27-OCT-2017. THE MOST RECENT INFORMATION WAS RECEIVED ON 16-JUN-2018. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT: THIS SPONTANEOUS CASE WAS REPORTED BY A PHARMACIST AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("CHRONIC PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922613) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), NAUSEA ("NAUSEA") AND WEIGHT DECREASED ("WEIGHT LOSS"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL FALLOPIAN TUBE/ESSURE REMOVAL PERFORMED). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, NAUSEA AND WEIGHT DECREASED OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL PAIN, NAUSEA, PELVIC PAIN AND WEIGHT DECREASED WITH ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-JUN-2018: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (REFERENCE NUMBER: MW5072823) ON 27-OCT-2017. THIS SPONTANEOUS CASE WAS REPORTED BY A PHARMACIST AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("CHRONIC PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. (B)(4)) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(4), THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), NAUSEA ("NAUSEA") AND WEIGHT DECREASED ("WEIGHT LOSS"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY AND ESSURE REMOVAL ). ESSURE WAS REMOVED ON (B)(6). AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, NAUSEA AND WEIGHT DECREASED OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL PAIN, NAUSEA, PELVIC PAIN AND WEIGHT DECREASED WITH ESSURE. INCIDENT AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836141 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 922613

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R