BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKIN STAPLE EXTRACTOR

    MDR report key: 4717908 · Received April 21, 2015

    Report

    Report Number
    1060680-2015-00015
    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. THE PRODUCT WAS TESTED AND WAS FOUND TO BE ACCEPTABLE AND FUNCTIONING AS INTENDED. A SCAR WAS ISSUED TO (B)(4), THE RAW MATERIAL SUPPLIER, WITH A DUE DATE OF (B)(6) 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) JUST STARTED USING THE SKIN STAPLE REMOVERS AND HAS CONCERNS ABOUT EMPLOYEES GETTING STUCK WITH THE EXTRACTED STAPLES. THE STAPLE EXTRACTOR IN A FEW INCIDENTS HAS GOTTEN STUCK BEFORE THE STAPLE IS EXTRACTED. THE INCISION ITSELF WAS PULLING OPEN AS THE CLINICIAN TRIED TO FREE THE STAPLER EXTRACTOR FROM UNDER THE STAPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263023 SKIN STAPLE EXTRACTOR KIT, SURGICAL INSTRUMENT, DISPOSABLE KDD DEROYAL INDUSTRIES 37840185

    Patients

    Seq Age Sex Outcome Treatment
    1