BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CCASC LAPAROTOMY PACK

    MDR report key: 19928467 · Received August 7, 2024

    Report

    Report Number
    3005011024-2022-00034
    Event Type
    Malfunction
    Date Received
    August 7, 2024
    Date of Event
    October 12, 2022
    Report Date
    August 26, 2024
    Manufacturer
    DEROYAL INDUSTRIES, INC..
    Product Code
    LRO
    UDI-DI
    00749756364430
    PMA / PMN Number
    K842648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A USER FACILITY MEDWATCH REPORT (B)(4) WAS RECIEVED ON 11/2/2022 REPORTING A HAIR FOUND IMBEDDED IN THE LAP PAD. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS SENT TO THE SUPPLIER (B)(4). THE SAMPLE WAS RETURNED TO DEROYAL FOR EVALUATION ON 11/7/2022. THIS INVESTIGATION IS ONGOING 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

    THE SAMPLE WAS RETURNED TO DEROYAL FOR EVALUATION ON 11/07/2022. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE SPONGE LAP SUPPLIER G D MEDICAL. ROOT CAUSE: IT WAS DETERMINED THAT CERTAIN WORKERS INVOLVED IN THE MANUFACTURING PROCESS WAS NOT PROPERLY FOLLOWING THE GOWNING PROCEDURE IN THE FOLDING WORKSHOP WHICH LED TO THE HAIR FOUND EMBEDDED. THE FOLLOWING CORRECTIVE AND PREVENTIVE ACTIONS HAVE TAKEN PLACE BY G D MEDICAL: THE EMPLOYEES INVOLVED IN THE MANUFACTURING WERE RE-TRAINED ON GOWNING PROCEDURES TO AVOID ANY HAIR LEFT ON THE PRODUCTS. WE WILL CONTINUE TO MONITOR AND TRACK ANY REOCCURRENCE OF SUCH ISSUE. PRODUCTION RECORDS WERE REVIEWED AND NO ISSUES WERE FOUND. AN INVENTORY CHECK OF THE SPONGE LAPS WAS MADE BY DEROYAL AND A TOTAL OF 125 OF THE 5-1918 SPONGE LAPS WERE INSPECTED WITH NO DISCREPANCIES IDENTIFIED. 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

    THE SAMPLE WAS RETURNED TO DEROYAL FOR EVALUATION ON 11/07/2022. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE SPONGE LAP SUPPLIER G D MEDICAL. ROOT CAUSE: IT WAS DETERMINED THAT CERTAIN WORKERS INVOLVED IN THE MANUFACTURING PROCESS WAS NOT PROPERLY FOLLOWING THE GOWNING PROCEDURE IN THE FOLDING WORKSHOP WHICH LED TO THE HAIR FOUND EMBEDDED. THE FOLLOWING CORRECTIVE AND PREVENTIVE ACTIONS HAVE TAKEN PLACE BY G D MEDICAL: THE EMPLOYEES INVOLVED IN THE MANUFACTURING WERE RE-TRAINED ON GOWNING PROCEDURES TO AVOID ANY HAIR LEFT ON THE PRODUCTS. WE WILL CONTINUE TO MONITOR AND TRACK ANY REOCCURRENCE OF SUCH ISSUE. PRODUCTION RECORDS WERE REVIEWED AND NO ISSUES WERE FOUND. AN INVENTORY CHECK OF THE SPONGE LAPS WAS MADE BY DEROYAL AND A TOTAL OF 125 OF THE 5-1918 SPONGE LAPS WERE INSPECTED WITH NO DISCREPANCIES IDENTIFIED. 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.

    Description of Event or Problem · 0

    HAIR FOUND IMBEDDED IN THE LAP PAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579850 CCASC LAPAROTOMY PACK GENERAL SURGERY TRAY (KIT) LRO DEROYAL INDUSTRIES, INC.. 89-10558 57392551 00749756364430

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown