BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALYARD* ORTHOPEDIC LOWER EXTREMITY DRAPES

    MDR report key: 17261520 · Received July 5, 2023

    Report

    Report Number
    3005997949-2023-00004
    Event Type
    Malfunction
    Date Received
    July 5, 2023
    Date of Event
    June 5, 2022
    Report Date
    August 1, 2023
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    PUI
    UDI-DI
    30680651480942
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE EVENT WAS NOT AVAILABLE FOR RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE EVENT WAS NOT AVAILABLE FOR RETURN. THE DEVICE HISTORY RECORD WAS REVIEWED FOR LOT NUMBER AC2131305F REPORTED. THE LOT MET MANUFACTURING PROCESS AND QUALITY SPECIFICATIONS PRIOR TO RELEASE. NO REWORK OR SPECIAL CONDITIONS WERE REPORTED. NO ROOT CAUSE WAS ESTABLISHED. PERSONNEL WAS NOTIFIED ABOUT THIS INCIDENT. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    A MAUDE ADVERSE EVENT REPORT 15515323 WAS FOUND WHEN PERFORMING MAUDE SEARCH FOR POSTMARKET SURVEILLANCE REPORT PREPARATION. SEARCH OF THE COMPLAINT DATABASE, DID NOT FIND THAT A PRIOR COMPLAINT WAS RECEIVED FOR THIS INCIDENT. AT THE END OF THE SURGICAL CASE WHEN REMOVING THE DRAPES OFF OF THE PATIENT, THE SURGEON NOTICED THAT THE LOWER EXTREMITY DRAPE WAS TORN UNDER THE PATIENT'S KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884267 HALYARD* ORTHOPEDIC LOWER EXTREMITY DRAPES SURGICAL DRAPES AND PACKS PUI O&M HALYARD, INC. 48094 AC2131305F 30680651480942

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown