BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERILE REGULATERD COLD PAD, UNIV, OAM, S. RH

    MDR report key: 5403655 · Received January 28, 2016

    Report

    Report Number
    MW5059827
    Event Type
    Injury
    Date Received
    January 28, 2016
    Date of Event
    January 26, 2016
    Report Date
    January 28, 2016
    Manufacturer
    DONJOY
    Product Code
    ILO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD ORTHOPEDIC KNEE SURGERY. A COLD THERAPY DEVICE (MACHINE AND PAD) ARE USED TO REDUCE PAIN AND SWELLING FROM JOINT SURGERY. THE PAD WAS DEFECTIVE AND LEAKED THE SOLUTION ONTO THE PATIENT'S DRESSING OVER THE INCISION. IT IS THOUGHT THAT THERE IS LOW RISK OF INFECTION FOR THE PATIENT FROM THE SOLUTION. TWO PATIENTS EXPERIENCED LEAKS FROM THE PADS ON THE SAME DAY AND DISTRIBUTOR REMOVED THE ENTIRE LOT # FROM STORAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55985 STERILE REGULATERD COLD PAD, UNIV, OAM, S. RH COLD THERAPY PAD ILO DONJOY 140298

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR