BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKIN STAPLER 35W

    MDR report key: 23876852 · Received December 23, 2025

    Report

    Report Number
    1060680-2025-00056
    Event Type
    Injury
    Date Received
    December 23, 2025
    Date of Event
    December 19, 2025
    Report Date
    March 12, 2026
    Manufacturer
    TELEFLEX LLC
    Product Code
    QQS
    UDI-DI
    00749756024372
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED, "PATIENT REPORTED WOUND HEALING ISSUES AT THE STAPLE SITE AND HAIR LOSS ALLEGEDLY CAUSED BY THE STAPLER." DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE, BUT IT WAS STATED IT WAS NOT AVAILABLE FOR RETURN. BECAUSE THE LOT NUMBER WAS NOT PROVIDED, THE WORK ORDER WAS NOT ABLE TO BE REVIEWED. AN INVENTORY CHECK WAS PERFORMED ON A BOX RETAINED AT DEROYAL AND FOUND TO BE ACCEPTABLE. THE RISK ANALYSIS WAS NOT REVIEWED AS THIS IS A PURCHASED ITEM AND DEROYAL DOES NOT OWN THE RISK DOCUMENTATION. A COMPLAINT TO SALES RATIO WAS CONDUCTED OVER THE PAST TWO YEARS AND FOUND TO BE 0.0032%. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WILL BE ISSUED TO THE SUPPLIER/MANUFACTURER, TELEFLEX LLC. THE SUPPLIER REPORTED THAT THEY WERE UNABLE TO PERFORM A FULL INVESTIGATION BECAUSE THE SAMPLE NOR THE LOT WERE PROVIDED. ROOT CAUSE: THE ROOT CAUSE WAS UNABLE TO BE DETERMINED BECAUSE THE SAMPLE NOR THE LOT WERE PROVIDED AND THEREFORE NO SPECIFIC INVESTIGATION WAS ABLE TO BE PERFORMED. CORRECTIVE AND PREVENTIVE ACTIONS: BECAUSE THE ROOT CAUSE WAS UNABLE TO BE DETERMINED, NO CORRECTIVE OR PREVENTIVE ACTIONS WERE TAKEN. DEROYAL WILL CONTINUE TO MONITOR FOR TRENDS AROUND THIS ITEM AND ISSUE. THIS INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED, "PATIENT REPORTED WOUND HEALING ISSUES AT THE STAPLE SITE AND HAIR LOSS ALLEGEDLY CAUSED BY THE STAPLER." DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE, BUT IT WAS STATED IT WAS NOT AVAILABLE FOR RETURN. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WILL BE ISSUED TO THE SUPPLIER/MANUFACTURER, TELEFLEX LLC. THIS INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED, "PATIENT REPORTED WOUND HEALING ISSUES AT THE STAPLE SITE AND HAIR LOSS ALLEGEDLY CAUSED BY THE STAPLER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2507379 SKIN STAPLER 35W STAPLER, SKIN QQS TELEFLEX LLC 25-3001 00749756024372

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other