BEUDAMED
    FDA Adverse Event Other Summary report: N

    BARD MALECOT DRAIN

    MDR report key: 121324 · Received September 18, 1997

    Report

    Report Number
    1018233-1997-00050
    Event Type
    Other
    Date Received
    September 18, 1997
    Date of Event
    August 14, 1997
    Manufacturer
    C.R. BARD, INC.
    Product Code
    FEW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN ATTEMPTING TO REMOVE THE SUPRAPUBIC DRAIN ON 2ND POST-OP DAY FOLLOWING PROSTATECTOMY, THE DRAIN BROKE & THE TIP OF DRAIN REMAINED IN PT'S BLADDER. PT WAS TAKEN TO SURGERY & UNDER SPINAL, DRAIN TIP WAS REMOVED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD MALECOT DRAIN LATEX MALECOT DRAIN FEW C.R. BARD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other