BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIMBERLY-CLARK NON-REINFORCED SURGICAL GOWN

    MDR report key: 628356 · Received August 17, 2005

    Report

    Report Number
    8030647-2005-00053
    Event Type
    Malfunction
    Date Received
    August 17, 2005
    Date of Event
    July 22, 2005
    Report Date
    August 17, 2005
    Manufacturer
    KIMBERLY-CLARK CORP.
    Product Code
    FYA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE DISTRIBUTOR FOR THE PRODUCT NOTIFIED KIMBERLY-CLARK THAT A DR HAD EXPERIENCED BLOOD STRIKE THROUGH IN THE ABDOMINAL AREA, FROM A SURGICAL PT WITH HEPATITIS C. THE DR'S SKIN WAS INTACT AND NO MEDICAL TREATMENT WAS REQUIRED. KIMBERLY-CLARK CORPORATION HAS NO FIRST HAND KNOWLEDGE OF THE ALLEGATIONS, BUT IS RELAYING INFO RECEIVED FROM OUTSIDE SOURCES PURSUANT TO FEDERAL REGULATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIMBERLY-CLARK NON-REINFORCED SURGICAL GOWN SURGICAL GOWN FYA KIMBERLY-CLARK CORP. NA AE504603A

    Patients

    Seq Age Sex Outcome Treatment
    1 *