BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICAL DRAPES AND PACKS

    MDR report key: 17419082 · Received July 28, 2023

    Report

    Report Number
    3005997949-2023-00006
    Event Type
    Malfunction
    Date Received
    July 28, 2023
    Report Date
    September 13, 2023
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    KKX
    UDI-DI
    30680651777448
    PMA / PMN Number
    K862801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE EVENT WAS NOT AVAILABLE FOR RETURN. THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE LOT NUMBER OF THE UNIT. THE LOT MET ALL MANUFACTURING PROCESS AND QUALITY SPECIFICATIONS PRIOR TO RELEASE. NO ABNORMALITIES WERE REPORTED DURING THE MANUFACTURING OF THIS PRODUCT. NO ROOT CAUSE CAN BE ESTABLISHED DUE TO THE LACK OF SAMPLE OR PICTURES. 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.

    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. LA ADA DE ACUNA, IS THE MANUFACTURER OF THE HALYARD BRANDED KIT. THE COMPLAINT COMPONENT TEGADERM, PART NUMBER 70019185 IS MANUFACTURED BY MYLAN TECHNOLOGIES, INC. (FDA REGISTRATION 1220747). A SUPPLIER CORRECTIVE ACTION (SCAR) WAS SUBMITTED TO THE MANUFACTURER ON 28JUL2023. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION AND RESPONSE BY THE MANUFACTURER. 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. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    THE TEGADERM TORE DURING USE, COMPROMISING OPHTHALMIC STERILE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1930166 SURGICAL DRAPES AND PACKS SURGICAL PACKS KKX O&M HALYARD, INC. 77744 AC2302005D 30680651777448

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown