BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PACK NO. 000054

    MDR report key: 4890946 · Received July 2, 2015

    Report

    Report Number
    4890946
    Event Type
    Malfunction
    Date Received
    July 2, 2015
    Date of Event
    June 25, 2015
    Report Date
    July 2, 2015
    Manufacturer
    PROFESSIONAL HOSPITAL SUPPLY INC
    Product Code
    LRP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    UPON OPENING PHS PACK, A HAIR WAS SEEN INSIDE THE PACK. THE ISSUE WAS IDENTIFIED PRIOR TO THE PATIENT COMING INTO THE OPERATING ROOM. NEW PACK REQUESTED, SET UP CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433148 CUSTOM PACK NO. 000054 KIT, SURGICAL INSTRUMENT, DISPOSABLE LRP PROFESSIONAL HOSPITAL SUPPLY INC * 1184184

    Patients

    Seq Age Sex Outcome Treatment
    1 *