BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL KNEE PACK

    MDR report key: 21409955 · Received February 19, 2025

    Report

    Report Number
    3005011024-2025-00001
    Event Type
    Malfunction
    Date Received
    February 19, 2025
    Date of Event
    February 10, 2025
    Report Date
    April 16, 2025
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    LRO
    PMA / PMN Number
    K842648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A COMPLAINT WAS RECEIVED ON 2/10/2025 REPORTING AN ISSUE IDENTIFIED WITH ADHESIVE DRAPE AND PAPER ADHESIVE IN PACKS ADHESIVE CAME OFF OF DRAPE AND STUCK TO PATIENT CAUSING SKIN TEAR. THE ACTUAL SAMPLE WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. HOWEVER, A PHOTO OF THE DRAPE WAS PROVIDED. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE DRAPE SUPPLIER CARDINAL HEALTH COMPANY. CARDINAL HEALTH COMPANY REVIEWED THE ASSEMBLY PROCESS FOR CODE 29436NC REPORTED FOR AGGRESSIVE ADHESIVE. THE CURRENT PROCESS MET THE SPECIFICATIONS REQUIRED. NO UNUSUAL OCCURRENCES WERE NOTED. THE REPORTED ISSUE COULD NOT BE FOUND IN OUR PROCESS. A PROBABLE ROOT CAUSE COULD NOT BE DETERMINED. DUE TO THE ROOT CAUSE FINDINGS THERE WERE NO CORRECTIVE OR PREVENTIVE ACTIONS TAKEN BY THE SUPPLIER CARDINAL HEALTH COMPANY. THERE HAVE BEEN NO OTHER REPORTS ON THIS SAME ISSUE AND THIS SAME ISSUE HAS NOT BEEN FOUND INTERNALLY. CARDINAL HEALTH COMPANY WILL CONTINUE TO TRACK AND TREND THROUGH THEIR MONITORING PROGRAMS AND TAKE ACTIONS AS APPLICABLE. AS A PREVENTIVE ACTION THIS PACK MEETS THE CRITERIA FOR ENTRY INTO DEROYAL'S QUALITY IMPROVEMENT PROGRAM, WHICH REQUIRES A HEIGHTENED LEVEL OF INSPECTION MOVING FORWARD. THIS PROGRAM WENT INTO EFFECT ON 1/30/2025. PRODUCTION RECORDS WERE REVIEWED, AND NO ISSUES WERE FOUND. AN INVENTORY CHECK OF THE DRAPE WAS MADE BY DEROYAL, A TOTAL OF (B)(4) OF 752405 WERE INSPECTED, AND NO DISCREPANCIES WERE IDENTIFIED DURING THE INSPECTION. 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 COMPLAINT WAS RECEIVED ON 2/102025 REPORTING AN ISSUE IDENTIFIED WITH ADHESIVE DRAPE AND PAPER ADHESIVE IN PACKS ADHESIVE CAME OFF OF DRAPE AND STUCK TO PATIENT CAUSING SKIN TEAR. THE ACTUAL SAMPLE WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. HOWEVER, A PHOTO OF THE DRAPE WAS PROVIDED. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE DRAPE SUPPLIER CARDINAL HEALTH COMPANY. 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.

    Description of Event or Problem · 0

    ISSUE IDENTIFIED WITH ADHESIVE DRAPE AND PAPER ADHESIVE IN PACKS ADHESIVE CAME OFF OF DRAPE AND STUCK TO PATIENT CAUSING SKIN TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2670061 TOTAL KNEE PACK GENERAL SURGERY TRAY (KIT) LRO DEROYAL INDUSTRIES, INC. 89-9286 61789914

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown