BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10138471 · Received June 10, 2020

    Report

    Report Number
    2951250-2020-08554
    Event Type
    Injury
    Date Received
    June 10, 2020
    Report Date
    May 27, 2021
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 638492) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED OVARIAN CYST, UTERINE LEIOMYOMA, ABDOMINAL PAIN, SITUATIONAL ANXIETY, VAGINITIS BACTERIAL, VITAMIN D DEFICIENCY, GENITAL HERPES, ANEMIA AND DIZZINESS. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), HYPERSENSITIVITY ("ALLERGIC REACTION"), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"), BLADDER DISORDER ("BLADDER PROBLEM"), URINARY TRACT DISORDER ("URINARY PROBLEM"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("UTI"), VAGINAL INFECTION ("VAGINAL INFECTION") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY, BILATERAL SALPINGECTOMY, UNILATERAL OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, HYPERSENSITIVITY, BLADDER DISORDER, URINARY TRACT DISORDER, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION AND VAGINAL DISCHARGE HAD RESOLVED AND THE PSYCHOLOGICAL TRAUMA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED BLADDER DISORDER, CYSTITIS, GENITAL HAEMORRHAGE, HYPERSENSITIVITY, PELVIC PAIN, PSYCHOLOGICAL TRAUMA, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE RIGHT ESSURE WAS PLACED, LEAVING FOUR TRAILING COILS. THE LEFT ESSURE WAS PLACED LEAVING FOUR TO FIVE TRAILING COILS. LOT NUMBER:638492 MANUFACTURING DATE: 20019-04 EXPIRATION DATE:2012-04 QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-MAY-2021: MR RECEIVED. REPORTER'S INFORMATION ADDED. MEDICAL HISTORY WERE ADDED. A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 638492) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), HYPERSENSITIVITY ("ALLERGIC REACTION"), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"), BLADDER DISORDER ("BLADDER PROBLEM"), URINARY TRACT DISORDER ("URINARY PROBLEM"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("UTI"), VAGINAL INFECTION ("VAGINAL INFECTION") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY, BILATERAL SALPINGECTOMY, UNILATERAL OOPHORECTOMY). ESSURE WAS REMOVED ON(B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, HYPERSENSITIVITY, BLADDER DISORDER, URINARY TRACT DISORDER, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION AND VAGINAL DISCHARGE HAD RESOLVED AND THE PSYCHOLOGICAL TRAUMA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED BLADDER DISORDER, CYSTITIS, GENITAL HAEMORRHAGE, HYPERSENSITIVITY, PELVIC PAIN, PSYCHOLOGICAL TRAUMA, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. LOT NUMBER:638492, MANUFACTURING DATE: 20019-04, EXPIRATION DATE:2012-04. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-JUN-2020: QUALITY SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT). A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS 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 ('PAIN') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 638492) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), HYPERSENSITIVITY ("ALLERGIC REACTION"), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"), BLADDER DISORDER ("BLADDER PROBLEM"), URINARY TRACT DISORDER ("URINARY PROBLEM"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("UTI"), VAGINAL INFECTION ("VAGINAL INFECTION") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY, BILATERAL SALPINGECTOMY, UNILATERAL OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, HYPERSENSITIVITY, BLADDER DISORDER, URINARY TRACT DISORDER, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION AND VAGINAL DISCHARGE HAD RESOLVED AND THE PSYCHOLOGICAL TRAUMA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED BLADDER DISORDER, CYSTITIS, GENITAL HAEMORRHAGE, HYPERSENSITIVITY, PELVIC PAIN, PSYCHOLOGICAL TRAUMA, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PIF RECEIVED: PREVIOUSLY REPORTED EVENT INJURY UPDATED TO NEW EVENT PELVIC PAIN. NEW EVENTS ADDED- GENITAL BLEEDING, PSYCH INJURY, ALLERGIC REACTION, BLADDER PROBLEM, URINARY PROBLEM, BLADDER INFECTION, UTI, VAGINAL INFECTION, VAGINAL DISCHARGE. CASE BECAME SERIOUS INCIDENT. REMOVAL DATE ADDED. LOT NUMBER 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
    601294 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 638492 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R