BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEROYAL INDUSTRIES, INC.

    MDR report key: 2484611 · Received December 22, 2011

    Report

    Report Number
    1058746-2011-00002
    Event Type
    Other
    Date Received
    December 22, 2011
    Report Date
    November 15, 2011
    Manufacturer
    UNIMED SURGICAL PRODUCTS, INC.
    Product Code
    GEI
    PMA / PMN Number
    962935
    Removal / Correction Number
    NONE
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    RECEIVED A COMPLAINT THAT AN ELECTROSURGICAL ELECTRODE TIP USED IN A CASE CAUSED A MINOR BURN, THE SAMPLE WAS RECEIVED, BUT HAD NOT BEEN USED. PART WAS ELECTRICALLY TESTED AND PASSED WITHOUT INCIDENT. DISTRIBUTOR HAS MADE SEVERAL ATTEMPTS TO CONTACT THE HOSPITAL BY PHONE AND LETTER WITH NO RESPONSE. HOSPITAL INFO WAS REQUESTED BUT NOT DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEROYAL INDUSTRIES, INC. ELECTROSURGICAL ELECTRODE GEI UNIMED SURGICAL PRODUCTS, INC. 45-00226 091409-07

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK