BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7055788 · Received November 23, 2017

    Report

    Report Number
    2951250-2017-07611
    Event Type
    Injury
    Date Received
    November 23, 2017
    Report Date
    October 25, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF IMPLANT"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND UNEVALUABLE EVENT ("DUST DRAINED") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B16006 (INVALID), B21583 (VALID)) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UNEVALUABLE EVENT (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), CYST ("CYSTS"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), NAUSEA ("NAUSEA"), ALLERGY TO METALS ("NICKEL ALLERGY"), PERINEAL PAIN ("PERINEAL PAIN"), ABDOMINAL PAIN UPPER ("STOMACH PAIN") AND BACK PAIN ("LOWER BACK PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL) AND SALPINGECTOMY (BILATERAL) AND SURGERY (ABLATION). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE, MENORRHAGIA, UNEVALUABLE EVENT, CYST, VAGINAL HAEMORRHAGE, NAUSEA, ALLERGY TO METALS, PERINEAL PAIN AND BACK PAIN OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN UPPER HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN UPPER, ALLERGY TO METALS, BACK PAIN, CYST, DEVICE DISLOCATION, GENITAL HAEMORRHAGE, MENORRHAGIA, NAUSEA, PERINEAL PAIN, UNEVALUABLE EVENT AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE NEED FOR ADDITIONAL SURGERY. DIAGNOSTIC RESULTS: ON (B)(6) 2013, HYSTEROSALPINGOGRAM TEST WAS PERFORMED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-JUL-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 SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF IMPLANT"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND SURGERY ("DUST DRAINED") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B16006, B21583) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), SURGERY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), CYST ("CYSTS"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), NAUSEA ("NAUSEA"), ALLERGY TO METALS ("NICKEL ALLERGY"), PERINEAL PAIN ("PERINEAL PAIN"), ABDOMINAL PAIN UPPER ("STOMACH PAIN") AND BACK PAIN ("LOWER BACK PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL) AND SALPINGECTOMY (BILATERAL)), SURGERY (ABLATION) AND SURGERY (ABLATION). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE, MENORRHAGIA, SURGERY, CYST, VAGINAL HAEMORRHAGE, NAUSEA, ALLERGY TO METALS, PERINEAL PAIN AND BACK PAIN OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN UPPER HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN UPPER, ALLERGY TO METALS, BACK PAIN, CYST, DEVICE DISLOCATION, GENITAL HAEMORRHAGE, MENORRHAGIA, NAUSEA, PERINEAL PAIN, SURGERY AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE NEED FOR ADDITIONAL SURGERY. DIAGNOSTIC RESULTS: ON (B)(6) 2013, HYSTEROSALPINGOGRAM TEST WAS PERFORMED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-JUN-2018: PFS RECEIVED - NEW EVENT "ABNORMAL BLEEDING (GENERAL), ABNORMAL BLEEDING (VAGINAL), ABNORMAL BLEEDING (MENORRHAGIA), NAUSEA, NICKEL ALLERGY, PERINEAL PAIN, STOMACH PAIN, LOWER BACK PAIN AND SURGERY: HAD A DUST DRAINED" WERE ADDED. LOT NUMBER WAS ADDED. 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

    NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF IMPLANT/ ONE OF THE SPRING WAS LOST DURING THE PROCEDURE AND WAS NOT FOUND"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)"), HEPATIC FAILURE ("LIVER FAILURE"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND UNEVALUABLE EVENT ("DUST DRAINED") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B16006(INVALID) B21583(VALID)) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED ENDOMETRIOSIS, CONSTIPATION AND ANXIETY. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), HEPATIC FAILURE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UNEVALUABLE EVENT (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), CYST ("CYSTS"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), NAUSEA ("NAUSEA"), ALLERGY TO METALS ("NICKEL ALLERGY"), PERINEAL PAIN ("PERINEAL PAIN"), ABDOMINAL PAIN UPPER ("STOMACH PAIN"), BACK PAIN ("LOWER BACK PAIN"), MOOD SWINGS ("HORMONAL CHANGES DESCRIBE:MOOD SWING"), DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)"), VAGINAL CYST ("OTHER INJURY(IES) OR COMPLICATION (S) PLEASE DESCRIBE:VAGINAL CYST") AND DRUG HYPERSENSITIVITY ("ALLERGIC REACTION TO ANESTHESIA"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL)/HYSTERECTOMY( FULL) AND SALPINGECTOMY (BILATERAL)), SURGERY (ABLATION) AND SURGERY (ABLATION). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, HEPATIC FAILURE, UNEVALUABLE EVENT, CYST, NAUSEA, ALLERGY TO METALS, PERINEAL PAIN, BACK PAIN, MOOD SWINGS, DYSMENORRHOEA, VAGINAL CYST AND DRUG HYPERSENSITIVITY OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, MENORRHAGIA, VAGINAL HAEMORRHAGE AND ABDOMINAL PAIN UPPER HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN UPPER, ALLERGY TO METALS, BACK PAIN, CYST, DEVICE DISLOCATION, DRUG HYPERSENSITIVITY, DYSMENORRHOEA, GENITAL HAEMORRHAGE, HEPATIC FAILURE, MENORRHAGIA, MOOD SWINGS, NAUSEA, PERINEAL PAIN, UNEVALUABLE EVENT, VAGINAL CYST AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE NEED FOR ADDITIONAL SURGERY. I HAD A HYSTERECTOMY AND THEN AN ALLERGIC REACTION TO THE ANESTHESIA AND WENT INTO LIVER FAILURE. DIAGNOSTIC RESULTS: ON (B)(6) 2013, HYSTEROSALPINGOGRAM TEST WAS PERFORMED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-OCT-2018: PFS RECEIVED: EVENT VAGINAL CYST, DYSMENORRHEA, MOOD SWING ADDED. REPORTERS ADDED. OUTCOME EVENT BLEEDING AND PAIN / PELVIC PAIN ADDED AS RECOVERED. MEDICAL HISTORY ADDED. PATIENT ETHNICITY ADDED. ANXIETY ADDED AS A HISTORICAL CONDITION. 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 SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF IMPLANT") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN AND CYST ("CYSTS"). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE). ESSURE WAS REMOVED IN (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION AND CYST OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED CYST AND DEVICE DISLOCATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE NEED FOR ADDITIONAL SURGERY. INCIDENT. NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. 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
    835191 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 B16006(INVALID) B21583(VALID)

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R