BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CMC LAPAROTOMY PACK

    MDR report key: 16131100 · Received January 10, 2023

    Report

    Report Number
    3005011024-2023-00002
    Event Type
    Malfunction
    Date Received
    January 10, 2023
    Date of Event
    January 6, 2023
    Report Date
    April 19, 2023
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    LRO
    UDI-DI
    00749756363778
    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 COMPLAINT WAS RECEIVED ON 1/6/2023 REPORTING HAIR IN PAPER TOWEL. THE SAMPLE WAS RETURNED TO DEROYAL FOR EVALUATION AND ONLY THE LOT NUMBER WAS PROVIDED TO O&M HALYARD, INC. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE PAPER TOWEL SUPPLIER O&M HALYARD, INC. THE TRUE ROOT CAUSE WAS UNABLE TO BE DETERMINED BY THE SUPPLIER O&M HALYARD, INC. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND CONFIRMED THAT THE LOT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. THE FOLLOWING CORRECTIVE AND PREVENTIVE ACTIONS HAVE BEEN TAKEN BY DRAPE SUPPLIER O&M HALYARD, INC. PERFORM MID-YEAR ANNUALLY QUALITY REINFORCEMENT ON JA-08365 FOR GOOD MANUFACTURING PRACTICES. NOTIFICATION OF THIS REPORTED INCIDENT WAS SENT TO THE MANUFACTURING AREA TO BRING AWARENESS OF THE ISSUE REPORTED. COMPLAINT DATA IS CONTINUOUSLY MONITORED TO IDENTIFY UPWARD TRENDS ASSOCIATED WITH THE REPORTED INCIDENT. PRODUCTION RECORDS WERE REVIEWED, AND NO ISSUES WERE FOUND. AN INVENTORY CHECK OF THE PAPER TOWEL WAS MADE BY DEROYAL, A TOTAL OF (B)(4) OF THE 1180883 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 1/6/2023 REPORTING HAIR IN PAPER TOWEL. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE PAPER TOWEL SUPPLIER (B)(4). THE SAMPLE HAS NOT BEEN RETURNED TO DEROYAL FOR EVALUATION AT THIS TIME. 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

    HAIR IN PAPER TOWEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205285 CMC LAPAROTOMY PACK GENERAL SURGERY TRAY (KIT) LRO DEROYAL INDUSTRIES, INC. 89-10560 58178127 00749756363778

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown