BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7056095 · Received November 23, 2017

    Report

    Report Number
    2951250-2017-07911
    Event Type
    Injury
    Date Received
    November 23, 2017
    Date of Event
    January 1, 2012
    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
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("PERFORATION"), PELVIC PAIN ("PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841532) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MISCARRIAGE. CONCURRENT CONDITIONS INCLUDED UTERINE BLEEDING. ON 26-AUG-2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL HAEMORRHAGE ("VAGINAL BLEEDING"), MENORRHAGIA ("MENORRHAGIA"), DYSMENORRHOEA ("DYSMENORRHEA"), DYSPAREUNIA ("DYSPAREUNIA"), FATIGUE ("FATIGUE") AND BACK PAIN ("LOWER BACK PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN LOWER. THE PATIENT WAS TREATED WITH SURGERY (08JUL2016 - TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED)) AND SURGERY (08JUL2016 - TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED)). ESSURE WAS REMOVED ON 8-JUL-2016. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA AND FATIGUE OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, DYSPAREUNIA AND BACK PAIN HAD RESOLVED. THE REPORTER CONSIDERED BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, UTERINE PERFORATION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DURING HYSTERECTOMY BLADDER WAS CUT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PFS AND MEDICAL RECORD RECEIVED. REPORTER AND PATIENT DEMOGRAPHICS WERE ADDED. UPDATED SUSPECT DRUG INDICATION. LOT NUMBER ADDED. CONCOMITANT DISEASE ADDED. EVENTS VAGINAL BLEEDING, MENORRHAGIA, DYSMENORRHEA, DYSPAREUNIA, FATIGUE, LOWER ABDOMEN PAIN, LOWER BACK PAIN 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 UTERINE PERFORATION ("PERFORATION"), PELVIC PAIN ("PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841532) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MISCARRIAGE. CONCURRENT CONDITIONS INCLUDED UTERINE BLEEDING. ON (B)(6)2011, THE PATIENT HAD ESSURE INSERTED. IN JANUARY 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL HAEMORRHAGE ("VAGINAL BLEEDING"), MENORRHAGIA ("MENORRHAGIA"), DYSMENORRHOEA ("DYSMENORRHEA"), DYSPAREUNIA ("DYSPAREUNIA"), FATIGUE ("FATIGUE") AND BACK PAIN ("LOWER BACK PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN LOWER. THE PATIENT WAS TREATED WITH SURGERY (B)(6)2016 - TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED)) AND SURGERY (B)(6)2016 - TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED)). ESSURE WAS REMOVED ON(B)(6) 2016. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA AND FATIGUE OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, DYSPAREUNIA AND BACK PAIN HAD RESOLVED. THE REPORTER CONSIDERED BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, UTERINE PERFORATION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DURING HYSTERECTOMY BLADDER WAS CUT QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)2018: QUALITY SAFETY EVALUATION OF PTC (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 SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND GENITAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED GENITAL HAEMORRHAGE AND PELVIC PAIN TO BE RELATED TO ESSURE. 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
    835425 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 841532

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other| R