BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKIN STAPLE EXTRACTOR

    MDR report key: 4717909 · Received April 21, 2015

    Report

    Report Number
    1060680-2015-00014
    Event Type
    Malfunction
    Date Received
    April 21, 2015
    Date of Event
    March 10, 2015
    Report Date
    April 17, 2015
    Manufacturer
    DEROYAL INDUSTRIES
    Product Code
    KDD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: THE QFI REPORT WAS REVIEWED TO OBTAIN THE SALES AND SIMILAR COMPLAINT INFORMATION. DEROYAL HAS SOLD (B)(4) CASES OF THE FINISHED GOOD FROM 2013 TO 2015. THERE HAVE BEEN NO PREVIOUS REPORTS OF THIS NATURE PRIOR TO THE CUSTOMER FILING TWO COMPLAINTS. RAW MATERIAL (B)(4) LOT NUMBER 1195857 WAS UTILIZED WITHIN THE FINISHED GOOD AND LOT NUMBER REPORTED. THE DEVICE IN USE DURING THE REPORTED INCIDENT WAS NOT RETURNED. HOWEVER, REPRESENTATIVE SAMPLES WERE RECEIVED FROM THE REPORTING CUSTOMER AND CONSISTED OF FOUR EACH OF THE DEVICE SEALED WITHIN THE PACKAGE. LOT NUMBER 36427356 WAS RETURNED AND NOT THE LOT NUMBER REPORTED. LOT MAPPING WAS PERFORMED AND IT WAS IDENTIFIED THAT ONE OF THE RAW MATERIAL LOT NUMBERS UTILIZED WAS THE SAME AS THE REPORTED LOT NUMBER: 36427356, (B)(4), 1195857; 36427356, (B)(4), 1135466. THE SAMPLES WERE FUNCTIONALLY TESTED BY REMOVING STAPLES FROM A BOX OF FOAM. ALL OF THE SKIN STAPLE REMOVERS PERFORMED AS INTENDED WITH NO IDENTIFIABLE ISSUES. A SCAR WAS ISSUED TO (B)(4)., THE RAW MATERIAL SUPPLIER, WITH A DUE DATE OF 04/20/2015. AS OF THE DATE OF THIS REPORT, THE SCAR HAS NOT BEEN RETURNED. THE INVESTIGATION IS INCOMPLETE AT THIS TIME. THIS REPORT WILL BE UPDATED WHEN NEW INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    (B)(6) MED. CTR. JUST STARTED USING THE SKIN STAPLE REMOVERS AND HAS CONCERNS ABOUT EMPLOYEES GETTING STUCK WITH THE EXTRACTED STAPLES. THE MAIN CONCERN IS THAT THE STAPLE GETS STUCK ON THE EXTRACTOR AND HAS TO BE PULLED OFF MANUALLY. IT DOES NOT FALL OFF WITHOUT ASSISTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262026 SKIN STAPLE EXTRACTOR KIT, SURGICAL INSTRUMENT, DISPOSABLE KDD DEROYAL INDUSTRIES 37840185

    Patients

    Seq Age Sex Outcome Treatment
    1