BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PADGETT MODEL S SLIMLINE ELECTRIC DERMATOME

    MDR report key: 7328899 · Received March 9, 2018

    Report

    Report Number
    3004608878-2018-00033
    Event Type
    Malfunction
    Date Received
    March 9, 2018
    Report Date
    February 20, 2018
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    GFD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COMPLETED ON (B)(6) 2018. THE DEVICE WAS NOT RETURNED FOR EVALUATION. FAILURE ANALYSIS VIA PHOTOS SUPPLIED BY END USER WAS USED TO IDENTIFY ROOT CAUSE. COMPLAINT EVENT IS CONFIRMED. ROOT CAUSE APPEARS TO BE MISUSE BY END USER. THE RED SUBSTANCE APPEARS TO BE AN UNAPPROVED LUBRICANT. THE BLACK SUBSTANCE ON THE HEAD AND WIDTH CLIP IS LIKELY THE ANODIZING COMING OFF THE PARTS DUE TO EITHER A REACTION TO THE RED SUBSTANCE OR FROM THE EXCESSIVE FRICTION CREATED BY THE BLADE BEING IMPROPERLY TIGHTENED. THE CONSTRAINED MOTION THE OSCILLATING PIN QUICKLY BROKE DOWN THE BLADE GROMMET TILL IT EVENTUALLY HITS THE BLADE. THEREFORE, YOU CAN SEE THE METAL FLAKES. THESE TYPES OF EVENTS TEND TO WEAR THE MOTOR, DESTROY THE DRIVE HUB, DAMAGE THE OSCILLATING PIN AND OBVIOUSLY DAMAGE THE HEAD AND CLIP. DHR - NO ABNORMALITIES RELATE TO REPORTED INCIDENT FOUND NOR WHERE THERE ANY VARIANCES, MRR¿S OR REWORKS ASSOCIATED WITH THE SERIAL NUMBER. LINKED TO MFG. REPORT NUMBER 3004608878-2018-00031, 3004608878-2018-00032, AND 3004608878-2018-00034.

    Description of Event or Problem · 1

    3 OF 4 REPORTS. IT WAS REPORTED THAT A 3539700 PADGETT MODEL S SLIMLINE ELECTRIC DERMATOME HAD ISSUES ON THE SURGERY DURING FIRST USAGE. IT WAS NOTED THAT THERE WERE RED OIL ON THE EQUIPMENT NEAR THE BLADES AND UPON USAGE THE EQUIPMENT LEFT STEEL POWDER NEAR THE BLADES. THE MEDICAL TEAM WAS WORRIED ABOUT THE RISK OF CONTAMINATING THE SKIN THAT ARE BEING REMOVED DURING THE USAGE OF THE EQUIPMENT AND COULD HARM THE PATIENT. NO PATIENT INJURY HAS BEEN REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170886 PADGETT MODEL S SLIMLINE ELECTRIC DERMATOME SKIN GRAFT PRODUCTS GFD INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1