BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGNATURE GLIDE

    MDR report key: 3021166 · Received March 21, 2013

    Report

    Report Number
    3021166
    Event Type
    Malfunction
    Date Received
    March 21, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 21, 2013
    Manufacturer
    MEDLINE INDUSTRIES INC
    Product Code
    KGO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US

    Narratives

    Description of Event or Problem · 1

    THE EVENT IS NOT A SINGULAR EVENT. IT IS RECURRING SINCE WE SWITCHED TO THE MEDLINE SURGEONS GLOVES. THE GLOVES RIP AND TEAR EASILY. A SURGEON EVEN LOST A GLOVE TIP DURING A SURGERY, HOWEVER, IT WAS RECOVERED. THE PACKAGING IS ALSO HARD TO OPEN AND REMAIN STERILE SO MULTIPLE PACKAGES ARE OPENED. THE GLOVES WERE RECENTLY REDESIGNED IN ORDER TO FIT THE BACK OF THE HAND BETTER, BUT THEY TEAR JUST AS BAD AS THE OLD DESIGN.======================MANUFACTURER RESPONSE FOR SURGEONS GLOVES, SIGNATURE GLIDE AND ALOETOUCH GREEN (PER SITE REPORTER).======================A SAMPLE WAS RETURNED TO THE MANUFACTURER FOR INSPECTION, HOWEVER WE HAVE MORE SAMPLES.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?HAND PROTECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117163 SIGNATURE GLIDE SURGEON'S GLOVES, LATEX KGO MEDLINE INDUSTRIES INC * 2012-352
    117164 ALOETOUCH GREEN SURGEON'S GLOVES, LATEX KGO MEDLINE INDUSTRIES INC * 112981370

    Patients

    Seq Age Sex Outcome Treatment
    1 *