BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PADGETT MODEL S SLIMLINE ELECTRIC DERMATOME

    MDR report key: 4777992 · Received May 14, 2015

    Report

    Report Number
    3004608878-2015-00153
    Event Type
    Malfunction
    Date Received
    May 14, 2015
    Report Date
    April 20, 2015
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    GFD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RETURNED. THE DEVICE EVAL IS IN PROGRESS. THE RESULT OF THE DEVICE EVAL WILL BE REPORTED IN A FOLLOW UP MDR SUBMISSION.

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 12MAY2016. THE INVESTIGATION INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE. REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINT HISTORY. RESULTS: DEVICE HISTORY RECORD REVIEWED FOR S-142 MANUFACTURED 02-20-2004 SHOW NO ABNORMALITIES RELATE TO REPORTED INCIDENT FOUND. THIS DEVICE PASSED ALL REQUIRED INSPECTION POINTS WITH NO ASSOCIATED MRR¿S, VARIANCES OR REWORK. THIS DEVICE WAS LAST SERVICED ON 10-20-2014. A TWO YEAR LOOKBACK FOR THIS REPORTED FAILURE AND OR RELATED TO \"MOTOR NOT WORKING \" FOR THIS PRODUCT ID SHOWS THAT (B)(4) COMPLAINTS WERE RECEIVED INCLUDING THIS CASE. CONCLUSION: IN SUMMARY: THIS CUSTOMER SENT IN S-1057 / 915460 WITH S-142 HEAD ASSEMBLY ATTACHED TO THE HANDLE: AS SUCH THE RETURNED HEAD WAS FOUND IN-TOLERANCE ON ALL CALIBRATION POINTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE MOTOR WAS NOT WORKING. THERE WAS NO PT CONTACT WHEN THE REPAIR NEEDS WERE FOUND. THE ISSUE WAS FOUND DURING CLEANING AND STERILIZATION. THE DEVICES WERE BEING INSPECTED AFTER CLEANING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316892 PADGETT MODEL S SLIMLINE ELECTRIC DERMATOME NONE GFD INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1