BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENROSE DRAINS STERILE LATEX

    MDR report key: 15770367 · Received November 10, 2022

    Report

    Report Number
    15770367
    Event Type
    Malfunction
    Date Received
    November 10, 2022
    Date of Event
    October 19, 2022
    Report Date
    October 25, 2022
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    NNZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE DRAINS ARE UNOPENED AND HAVE PERFORATIONS/HOLES IN THE DRAIN. THEY APPEAR TO HAVE DRY ROT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461213 PENROSE DRAINS STERILE LATEX SYSTEM, URINE DRAINAGE, CLOSED, FOR NONINDWELLING CATHETER, STERILE NNZ MEDLINE INDUSTRIES, LP 6051901002

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown