BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROVAC¿ BLADDER EVACUATOR

    MDR report key: 7462373 · Received April 25, 2018

    Report

    Report Number
    3005099803-2018-01284
    Event Type
    Malfunction
    Date Received
    April 25, 2018
    Date of Event
    April 9, 2018
    Report Date
    April 10, 2018
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFD
    UDI-DI
    08714729033769
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 BLADDER EVACUATOR DEVICE WAS UNPACKED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, THE PACKAGING OF THE DEVICE WAS NOTED TO BE DAMAGED. IT WAS NOTICED THAT THE PACKAGING HAS A CUT. REPORTEDLY, THIS WAS NOT USED IN A PATIENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303548 UROVAC¿ BLADDER EVACUATOR EVACUATOR, BLADDER, MANUALLY OPERATED FFD BOSTON SCIENTIFIC - SPENCER M0067301251 20872043 08714729033769

    Patients

    Seq Age Sex Outcome Treatment
    1