BEUDAMED
    FDA Adverse Event Summary report: N

    ZERTYL P-METER

    MDR report key: 22095 · Received March 28, 1995

    Report

    Report Number
    39749-1995-09001
    Date Received
    March 28, 1995
    Report Date
    March 21, 1995
    Manufacturer
    ZERTYL MEDICAL, INC.
    Product Code
    BZH
    Report Source
    Distributor report

    Narratives

    Description of Event or Problem · 1

    USER ERROR - NOT ADVERSE EVENT AND/OR PRODUCT PROBLEM.PRODUCT WAS PLACED DIRECTLY ON AN ABDOMINAL GRAFT DURING SURGERY. PRODUCT IS LABELED AND SOLD AS NON-STERILE FOR TOPICAL USE. PT WAS REPORTEDLY RELEASED FROM HOSPITAL WITHOUT ANY ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZERTYL P-METER PULSE BLOOD FLOW MONITOR (DOPPLER) BZH ZERTYL MEDICAL, INC. P/METER DOPPLER FLOW METER UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 *