BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 8195066 · Received December 26, 2018

    Report

    Report Number
    2951250-2018-05294
    Event Type
    Injury
    Date Received
    December 26, 2018
    Report Date
    August 17, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ('CHRONIC ABDOMINAL PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 910509) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED ENDOMETRITIS AND OVARIAN CYST. IN 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"), BACK PAIN ("BACK PAIN"), PELVIC PAIN ("PELVIC PAIN FEMALE CHRONIC"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MIGRAINE ("MIGRAINE") AND URINARY TRACT INFECTION ("BLADDER/ URINARY PROBLEMS: UTI"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL), SALPINGECTOMY (BILATERAL), OOPHORECTOMY (UNILATERAL)). ESSURE WAS REMOVED ON (B)(6)2015. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, BACK PAIN, PELVIC PAIN, DYSMENORRHOEA, MIGRAINE AND URINARY TRACT INFECTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, BACK PAIN, DYSMENORRHOEA, MIGRAINE, PELVIC PAIN AND URINARY TRACT INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE INSERTION DATE (B)(6)2013 AND 2012. PATIENT RECEIVED TREATMENT FOR BACK, ABDOMINAL ,PELVIC PAIN, DYSMENORRHEA, MIGRAINE, UTI INSERTION DETAILS:- LEFT: 2, RIGHT: 2. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)2020: MEDICAL RECORDS RECIVED, NEW REPORTER, LOT NUMBER, PATIENT CONCOMITANT CONDITION ADDED. PROCEED WITH FOLLOW-UP 2ND WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE 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 ABDOMINAL PAIN ('CHRONIC ABDOMINAL PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"), BACK PAIN ("BACK PAIN"), PELVIC PAIN ("PELVIC PAIN FEMALE CHRONIC"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MIGRAINE ("MIGRAINE") AND URINARY TRACT INFECTION ("BLADDER/ URINARY PROBLEMS: UTI"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL), SALPINGECTOMY (BILATERAL), OOPHORECTOMY (UNILATERAL)). ESSURE WAS REMOVED ON(B)(6) 2015. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, BACK PAIN, PELVIC PAIN, DYSMENORRHOEA, MIGRAINE AND URINARY TRACT INFECTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, BACK PAIN, DYSMENORRHOEA, MIGRAINE, PELVIC PAIN AND URINARY TRACT INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE INSERTION DATE (B)(6) 2013 AND 2012. PATIENT RECEIVED TREATMENT FOR BACK, ABDOMINAL ,PELVIC PAIN, DYSMENORRHEA, MIGRAINE, UTI. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-SEP-2019: PFS RECEIVED EVENTS " BACK PAIN, PELVIC PAIN, DYSMENORRHEA, UTI, MIGRAINE" WERE ADDED. PATIENT DEMOGRAPHICS AND REPORTER INFORMATION WERE ADDED. INCIDENT NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES 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 ABDOMINAL PAIN ("CHRONIC ABDOMINAL PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"). THE PATIENT WAS TREATED WITH SURGERY (SURGERY TO REMOVE THE ESSURE). ESSURE WAS REMOVED IN (B)(6) 2016. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN AND ABDOMINAL PAIN LOWER TO BE RELATED TO ESSURE. INCIDENT NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1034677 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 910509 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R