BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRANSETTE 3R

    MDR report key: 13016 · Received April 29, 1994

    Report

    Report Number
    MW1001792
    Event Type
    Other
    Date Received
    April 29, 1994
    Manufacturer
    SPECTRUM MEDICAL, INC.
    Product Code
    JSC
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    AFTER MULTIPLE REPORTS OF ORGANISM GROWTH ON THIS CULTURE MEDIUM, ON SPECIMENS WHICH SHOULD BE NEGATIVE SUCH AS BONE ALLOGRAFTS, THIS CULTURE MEDIUM WAS CULTURED AND FOUND TO BE CONTAMINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSETTE 3R RAYON SWAB ON PLASTIC SHAFT (MODIFIED MEDIUM) JSC SPECTRUM MEDICAL, INC. 174323 902

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other