BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10579192 · Received September 24, 2020

    Report

    Report Number
    2951250-2020-14636
    Event Type
    Injury
    Date Received
    September 24, 2020
    Report Date
    September 29, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') AND KIDNEY INFECTION ('BLADDER OR URINARY PROBLEMS OR CHANGES KIDNEY INFECTION') IN A 31-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 821581-INV,821681-INV) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED DEPRESSION. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN 2013, THE PATIENT EXPERIENCED KIDNEY INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN 2014, THE PATIENT EXPERIENCED MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS") AND MIGRAINE ("MIGRAINES / HEADACHES"). IN 2015, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("PAIN"). IN 2016, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), TOOTH DISORDER ("DENTAL PROBLEMS"), FATIGUE ("FATIGUE") AND ALOPECIA ("HAIR LOSS"). IN 2018, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), NAUSEA ("NAUSEA"), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY") AND BLADDER DISORDER ("BLADDER PROBLEM"). THE PATIENT WAS TREATED WITH ANTIBIOTICS, IRON AND SURGERY (ESSURE REMOVED). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, KIDNEY INFECTION, ABDOMINAL PAIN, MOOD SWINGS, VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT INFECTION, FEMALE SEXUAL DYSFUNCTION, DEPRESSION, MIGRAINE, NAUSEA, TOOTH DISORDER, FATIGUE, ALOPECIA, PSYCHOLOGICAL TRAUMA AND BLADDER DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, BLADDER DISORDER, DEPRESSION, FATIGUE, FEMALE SEXUAL DYSFUNCTION, KIDNEY INFECTION, MENORRHAGIA, MIGRAINE, MOOD SWINGS, NAUSEA, PELVIC PAIN, PSYCHOLOGICAL TRAUMA, TOOTH DISORDER, URINARY TRACT INFECTION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: 3 COILS ON LEFT AND 1 ON RIGHT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION. BATCH NUMBER : 821581,821681-NOT VALID. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 25-SEP-2020: QUALITY-SAFETY EVALUATION OF PTC. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION 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 PELVIC PAIN ('PELVIC PAIN') AND KIDNEY INFECTION ('BLADDER OR URINARY PROBLEMS OR CHANGES KIDNEY INFECTION') IN A (B)(6) YEAR OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 821581-INV,821681-INV) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED DEPRESSION. IN 2013, THE PATIENT EXPERIENCED KIDNEY INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN 2014, THE PATIENT EXPERIENCED MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS") AND MIGRAINE ("MIGRAINES / HEADACHES"). IN 2015, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("PAIN"). IN 2016, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), TOOTH DISORDER ("DENTAL PROBLEMS"), FATIGUE ("FATIGUE") AND ALOPECIA ("HAIR LOSS"). IN 2018, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), NAUSEA ("NAUSEA"), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY") AND BLADDER DISORDER ("BLADDER PROBLEM"). THE PATIENT WAS TREATED WITH ANTIBIOTICS, IRON AND SURGERY (ESSURE REMOVED). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, KIDNEY INFECTION, ABDOMINAL PAIN, MOOD SWINGS, VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT INFECTION, FEMALE SEXUAL DYSFUNCTION, DEPRESSION, MIGRAINE, NAUSEA, TOOTH DISORDER, FATIGUE, ALOPECIA, PSYCHOLOGICAL TRAUMA AND BLADDER DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, BLADDER DISORDER, DEPRESSION, FATIGUE, FEMALE SEXUAL DYSFUNCTION, KIDNEY INFECTION, MENORRHAGIA, MIGRAINE, MOOD SWINGS, NAUSEA, PELVIC PAIN, PSYCHOLOGICAL TRAUMA, TOOTH DISORDER, URINARY TRACT INFECTION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: 3 COILS ON LEFT AND 1 ON RIGHT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION. BATCH NUMBER : 821581,821681-NOT VALID. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-SEP-2020: PIF RECEIVED : CASE WAS UPGRADED TO INCIDENT. ESSURE REMOVAL DATE ADDED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045881 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 821581-INV,821681-INV 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other| R