BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10142267 · Received June 11, 2020

    Report

    Report Number
    2951250-2020-08622
    Event Type
    Injury
    Date Received
    June 11, 2020
    Report Date
    July 16, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 901328), INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, 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"), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"), BLADDER DISORDER ("BLADDER PROBLEM"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("UTI"), VAGINAL INFECTION ("VAGINAL INFECTION") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, 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, PELVIC PAIN, PSYCHOLOGICAL TRAUMA, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON (B)(6) 2013, ESSURE CONFIRMATION TEST(S) UNSPECIFIED -RESULT UNKNOWN. LOT NUMBER#: 901328, MANUFACTURING DATE: 2011-09, EXPIRATION DATE: 2014-09. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-JUN-2020, QUALITY-SAFETY EVALUATION OF PTC. WE RECEIVED A LOT NUMBER IN THIS CASE. 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. 901328) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, 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"), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"), BLADDER DISORDER ("BLADDER PROBLEM"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("UTI"), VAGINAL INFECTION ("VAGINAL INFECTION") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, 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, PELVIC PAIN, PSYCHOLOGICAL TRAUMA, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE ON (B)(6) 2013: ESSURE CONFIRMATION TEST(S) UNSPECIFIED -RESULT UNKNOWN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PFS RECEIVED-PREVIOUSLY REPORTED EVENT INJURY NOS WAS REPLACED WITH PAIN. NEW EVENTS ABNORMAL BLEEDING, PSY INJURY, BLADDER PROBLEM, URINARY PROBLEM, BLADDER INFECTION, VAGINAL INFECTION, VAGINAL DISCHARGE WERE ADDED. ESSURE REMOVAL DETAILS WERE ADDED. LOT NUMBER WAS RECEIVED. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608324 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 901328 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R