BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UROVAC¿ BLADDER EVACUATOR

    MDR report key: 6865340 · Received September 14, 2017

    Report

    Report Number
    3005099803-2017-02788
    Event Type
    Injury
    Date Received
    September 14, 2017
    Report Date
    August 24, 2017
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FFD
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. IT WAS REPORTED THE DEVICE WAS NOT USED PAST ITS EXPIRY DATE. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROVAC BLADDER EVACUATOR WAS USED ON A PROCEDURE PERFORMED TWO AND HALF YEAR AGO. ACCORDING TO THE COMPLAINANT, THE PATIENT SUFFERED AN INJURY DUE TO A UROLOGY DEVICE USED IN A GYNECOLOGICAL PROCEDURE. HOWEVER, THE NATURE AND CAUSE OF THE INJURY IS UNKNOWN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL PATIENT AND PROCEDURE INFORMATION HAVE BEEN UNSUCCESSFUL. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645629 UROVAC¿ BLADDER EVACUATOR EVACUATOR, BLADDER, MANUALLY OPERATED FFD BOSTON SCIENTIFIC - COSTA RICA (COYOL) M0067301251

    Patients

    Seq Age Sex Outcome Treatment
    1 Other