BEUDAMED
    FDA Adverse Event Other Summary report: N

    90-1761 ARTHROSCOPY TRACEPAK

    MDR report key: 376313 · Received February 6, 2002

    Report

    Report Number
    1057373-2002-00007
    Event Type
    Other
    Date Received
    February 6, 2002
    Date of Event
    December 26, 2001
    Report Date
    January 7, 2002
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    KDD
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ACE BANDAGE PUT ON PT'S LEG FOR SUPPORT FOLLOWING KNEE SURGERY CAUSED A RASH AROUND SITE AND ON OTHER LEG. ALLEGED INCIDENT DEVICE FROM A 90-1761 ARTHROSCOPY TRACEPAK COMPONENT NUMBER 5-19371 ELASTIC BANDAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 90-1761 ARTHROSCOPY TRACEPAK VCPOVOLUME CUSTOM TRACEPAK ORTHO KDD DEROYAL INDUSTRIES, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other