BEUDAMED
    FDA Adverse Event Other Summary report: N

    9006-00 CUTAWAY SLING & SWATHE UNIV

    MDR report key: 336733 · Received June 5, 2001

    Report

    Report Number
    1123835-2001-00002
    Event Type
    Other
    Date Received
    June 5, 2001
    Date of Event
    May 1, 2001
    Report Date
    May 3, 2001
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    ILI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR CALLED IN THIS COMPLAINT AFTER RECEIVING A CALL FROM A PATIENT WEARING A SWING AND SWATHE DEVICE. THE PATIENT COMPLAINED OF RUNNING EYES, RASH AND SWELLING WHICH WAS ATTRIBUTED TO PRODUCT. THE PATIENT'S ROOM WAS CLEARLY LABELED "NO LATEX" AND THE DOCTOR IS SURE THE PRODUCT CONTAINS LATEX, AND THAT THE PATIENT IS HAVING A TYPICAL LATEX ALLERGY REACTION. A PICTURE OF THE DEVICE WAS FAXED TO CONFIRM THE PRODUCT NUMBER. REPLACEMENT SENT 9020-02. THE PATIENT WILL NOT RETURN THE DEVICE AND WILL OFFER NO OTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25913 9006-00 CUTAWAY SLING & SWATHE UNIV TLH TOP-OF-THE-LINE SHOULDER PRODS ILI DEROYAL INDUSTRIES, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other