BEUDAMED
    FDA Adverse Event Other Summary report: N

    1190917 19" CANVAS TRI-PANEL KNEE UNIV

    MDR report key: 266301 · Received March 30, 2000

    Report

    Report Number
    1037420-2000-00002
    Event Type
    Other
    Date Received
    March 30, 2000
    Date of Event
    January 27, 2000
    Report Date
    February 24, 2000
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    ITQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    KNEE IMMOBILIZER WAS APPLIED TO PT IMMEDIATELY AFTER SURGERY OF THE KNEE. WITHIN 24 HOURS AFTER WEARING THE IMMOBILIZER, PT REPORTED PERONEAL NERVE PALSY IN THE AREA OF THE FIBIA. AFTER PARTICIPATING IN THE PHYSICAL THERAPY TREATMENT PRESCRIBED FOR POSTSURGICAL HEALING, THE NERVE PALSY DIMINISHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1190917 19" CANVAS TRI-PANEL KNEE UNIV BLC BLUE LINE KNEE PRODUCTS ITQ DEROYAL INDUSTRIES, INC. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other PHYSICAL THERAPY RELATED TO SURGICAL RECOVERY.