BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7062485 · Received November 28, 2017

    Report

    Report Number
    2951250-2017-09067
    Event Type
    Injury
    Date Received
    November 28, 2017
    Date of Event
    December 1, 2011
    Report Date
    August 20, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN / PAIN"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") AND UTERINE HAEMORRHAGE ("ABNORMAL UTERINE BLEEDING") IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 901333, 863579) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED METRORRHAGIA AND POST COITAL BLEEDING. CONCOMITANT PRODUCTS INCLUDED HYDROCODONE. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("PAINFUL MENSES / DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("HEAVY MENSES / MENORRHAGIA"), BOWEL MOVEMENT IRREGULARITY ("BOWEL PROBLEMS: IRREGULAR BOWEL"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), WEIGHT INCREASED ("WEIGHT GAIN"), BACK PAIN ("BACK PAIN") AND MUSCULOSKELETAL CHEST PAIN ("RIB PAIN"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED MUSCULOSKELETAL STIFFNESS ("STIFFNESS IN BODY"). IN (B)(6) 2012, THE PATIENT EXPERIENCED GASTRIC INFECTION ("INFECTION (OTHER) DESCRIBE: STOMACH") AND ENTEROCOLITIS FUNGAL ("INFECTION (OTHER) DESCRIBE: COLON"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), HYPERTONIC BLADDER ("OVERACTIVE BLADDER") AND ABDOMINAL DISTENSION ("BLOATING"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A TOTAL LAPAROSCOPIC HYSTERECTOMY, SALPINGECTOMY AND CYSTOSCOPY WITH REMOVAL OF ESSURE). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, BACK PAIN AND MUSCULOSKELETAL CHEST PAIN WAS RESOLVING, THE GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, GASTRIC INFECTION, ENTEROCOLITIS FUNGAL, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, HEADACHE, NAUSEA, DYSPAREUNIA, FATIGUE, WEIGHT INCREASED, ABDOMINAL DISTENSION AND MUSCULOSKELETAL STIFFNESS OUTCOME WAS UNKNOWN AND THE UTERINE HAEMORRHAGE, ABDOMINAL PAIN, HYPERTONIC BLADDER, DYSMENORRHOEA, MENORRHAGIA AND BOWEL MOVEMENT IRREGULARITY HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, BACK PAIN, BLADDER DISORDER, BOWEL MOVEMENT IRREGULARITY, DYSMENORRHOEA, DYSPAREUNIA, ENTEROCOLITIS FUNGAL, FATIGUE, GASTRIC INFECTION, GENITAL HAEMORRHAGE, HEADACHE, HYPERTONIC BLADDER, MENORRHAGIA, MIGRAINE, MUSCULOSKELETAL CHEST PAIN, MUSCULOSKELETAL STIFFNESS, NAUSEA, PELVIC PAIN, URINARY TRACT DISORDER, UTERINE HAEMORRHAGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT'S SYMPTOMS SUBSTANTIALLY RESOLVED AFTER THE (B)(6) 2014 SURGERY. CURRENT WEIGHT 175 LBS. IF YES, DESCRIBE WHEN YOU TOOK LEAVE AND THE REASON: DATE LEAVE BEGAN: (B)(6) 2014, DATE LEAVE ENDED: (B)(6) 2015, REASON: PARTIAL HYSTERECTOMY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM: ON (B)(6) 2012: OCCLUSION OF BOTH THE RIGHT AND LEFT FALLOPIANTUBE. BATCH NUMBER: 863579, EXP DATE:2014/05, MAN DATE:2011/05. BATCH NUMBER: 901333, EXP DATE: 2014/09, MAN DATE:2011/09. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-AUG-2018: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINTS. 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 PELVIC PAIN ("SEVERE PELVIC PAIN / PAIN"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") AND UTERINE HAEMORRHAGE ("ABNORMAL UTERINE BLEEDING") IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 901333, 863579) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED METRORRHAGIA AND POST COITAL BLEEDING. CONCOMITANT PRODUCTS INCLUDED HYDROCODONE. IN DECEMBER 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("PAINFUL MENSES / DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("HEAVY MENSES / MENORRHAGIA"), BOWEL MOVEMENT IRREGULARITY ("BOWEL PROBLEMS: IRREGULAR BOWEL"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), WEIGHT INCREASED ("WEIGHT GAIN"), BACK PAIN ("BACK PAIN") AND MUSCULOSKELETAL CHEST PAIN ("RIB PAIN"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN JANUARY 2012, THE PATIENT EXPERIENCED MUSCULOSKELETAL STIFFNESS ("STIFFNESS IN BODY"). IN DECEMBER 2012, THE PATIENT EXPERIENCED GASTRIC INFECTION ("INFECTION (OTHER) DESCRIBE: STOMACH") AND ENTEROCOLITIS FUNGAL ("INFECTION (OTHER) DESCRIBE: COLON"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), HYPERTONIC BLADDER ("OVERACTIVE BLADDER") AND ABDOMINAL DISTENSION ("BLOATING"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A TOTAL LAPAROSCOPIC HYSTERECTOMY, SALPINGECTOMY AND CYSTOSCOPY WITH REMOVAL OF ESSURE). ESSURE WAS REMOVED ON (B)(6)2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, BACK PAIN AND MUSCULOSKELETAL CHEST PAIN WAS RESOLVING, THE GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, GASTRIC INFECTION, ENTEROCOLITIS FUNGAL, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, HEADACHE, NAUSEA, DYSPAREUNIA, FATIGUE, WEIGHT INCREASED, ABDOMINAL DISTENSION AND MUSCULOSKELETAL STIFFNESS OUTCOME WAS UNKNOWN AND THE UTERINE HAEMORRHAGE, ABDOMINAL PAIN, HYPERTONIC BLADDER, DYSMENORRHOEA, MENORRHAGIA AND BOWEL MOVEMENT IRREGULARITY HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, BACK PAIN, BLADDER DISORDER, BOWEL MOVEMENT IRREGULARITY, DYSMENORRHOEA, DYSPAREUNIA, ENTEROCOLITIS FUNGAL, FATIGUE, GASTRIC INFECTION, GENITAL HAEMORRHAGE, HEADACHE, HYPERTONIC BLADDER, MENORRHAGIA, MIGRAINE, MUSCULOSKELETAL CHEST PAIN, MUSCULOSKELETAL STIFFNESS, NAUSEA, PELVIC PAIN, URINARY TRACT DISORDER, UTERINE HAEMORRHAGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT'S SYMPTOMS SUBSTANTIALLY RESOLVED AFTER THE (B)(6) 2014 SURGERY. CURRENT WEIGHT 175 LBS. IF YES, DESCRIBE WHEN YOU TOOK LEAVE AND THE REASON: DATE LEAVE BEGAN: (B)(6) 2014 DATE LEAVE ENDED: FEB2015 REASON: PARTIAL HYSTERECTOMY DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: OCCLUSION OF BOTH THE RIGHT AND LEFT FALLOPIANTUBE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: EVENTS- "ABNORMAL BLEEDING (GENERAL), ABNORMAL BLEEDING (VAGINAL), INFECTION (OTHER) DESCRIBE: STOMACH, INFECTION (OTHER) DESCRIBE: COLON, BLADDER PROBLEMS, URINARY PROBLEMS OR CHANGES, MIGRAINES, HEADACHES, NAUSEA, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), FATIGUE, WEIGHT GAIN, BLOATING, STIFFNESS IN BODY, BACK PAIN, RIB PAIN" , REPORTER, LOT NUMBER, CONCOMITTANT DRUG ADDED FROM PFS. ON (B)(6) 2018: REPORTER, CONCOMITTANT CONDITION ADDED FROM MEDICAL RECORD. 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 ("SEVERE PELVIC PAIN") AND UTERINE HAEMORRHAGE ("ABNORMAL UTERINE BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6), THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), HYPERTONIC BLADDER ("OVERACTIVE BLADDER"), DYSMENORRHOEA ("PAINFUL MENSES"), MENORRHAGIA ("HEAVY MENSES / MENORRHAGIA") AND GASTROINTESTINAL DISORDER ("BOWEL PROBLEMS"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A TOTAL LAPAROSCOPIC HYSTERECTOMY, SALPINGECTOMY AND CYSTOSCOPY). ESSURE WAS REMOVED ON (B)(6). AT THE TIME OF THE REPORT, THE PELVIC PAIN, UTERINE HAEMORRHAGE, ABDOMINAL PAIN, HYPERTONIC BLADDER, DYSMENORRHOEA, MENORRHAGIA AND GASTROINTESTINAL DISORDER HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSMENORRHOEA, GASTROINTESTINAL DISORDER, HYPERTONIC BLADDER, MENORRHAGIA, PELVIC PAIN AND UTERINE HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT'S SYMPTOMS SUBSTANTIALLY RESOLVED AFTER THE (B)(6) SURGERY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6): OCCLUSION OF BOTH THE RIGHT AND LEFT FALLOPIAN TUBE. 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
    843309 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 901333, 863579

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other| R HYDROCODONE| HYDROCODONE