BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENERAL SURGERY TRAY (KIT)

    MDR report key: 16132347 · Received January 10, 2023

    Report

    Report Number
    1047429-2022-00001
    Event Type
    Injury
    Date Received
    January 10, 2023
    Date of Event
    December 9, 2022
    Report Date
    April 25, 2023
    Manufacturer
    AVID MEDICAL
    Product Code
    LRO
    UDI-DI
    10809160364796
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. UPON COMPLETION OF THE INVESTIGATION; A FOLLOW-UP REPORT WILL BE FILED. ALL INFORMATION REASONABLY KNOWN AS OF 10JAN2023 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. O&M HALYARD, INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. 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 O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED. DURING THIS INSPECTION, NO ISSUES WERE DETECTED. PHOTOS AND SAMPLES WERE NOT RECEIVED, DETAILS HAVE BEEN FORWARDED TO 3M WITH A REQUEST FOR DOCUMENTATION OUTLINING THEIR FINDINGS AND ANY CORRECTIVE ACTIONS TAKEN. AN INSPECTION OF OUR IN-HOUSE STOCK WAS COMPLETED. WE NO LONGER HAVE THE COMPLAINED LOT ON HAND. AS A PRECAUTION ADDITIONAL LOTS ON HAND WERE INSPECTED. DURING THE REVIEW THE REPORTED ISSUE COULD NOT BE DETECTED. NO SUPPLIER RESPONSE HAS BEEN OBTAINED TO-DATE FROM 3M. AVID MEDICAL WILL CONTINUE TO TRACK AND TREND FOR ANY FUTURE RECURRENCE OF THIS ISSUE AND EVALUATE FOR FURTHER CORRECTIVE ACTIONS. ALL INFORMATION REASONABLY KNOWN AS OF 25APR2023 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY O&M HALYARD, INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. 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 O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    AVID MEDICAL COMPLAINT # (B)(4). AVID MEDICAL RECEIVED A COMPLAINT ON 12/12/2022 THAT STATED "WHEN THE 3M 1015 DRAPE WAS REMOVED, THE ADHESIVE LIFTED THE PATIENT¿S SKIN." MEDICAL TREATMENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204381 GENERAL SURGERY TRAY (KIT) GENERAL SURGERY TRAY LRO AVID MEDICAL VALV219-02 1520686 10809160364796

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention