BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPG RSEBD STRL XRAY FOAM 1/4" 200/BX

    MDR report key: 18133702 · Received November 14, 2023

    Report

    Report Number
    3011137372-2023-00248
    Event Type
    Malfunction
    Date Received
    November 14, 2023
    Date of Event
    November 2, 2023
    Report Date
    November 7, 2023
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDY
    UDI-DI
    04026704417681
    PMA / PMN Number
    K913302
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). OTHER REMARKS: N/A, CORRECTED DATA: N/A.

    Additional Manufacturer Narrative · 0

    (B)(4). ADDITIONAL INFORMATINO RECEIVED ON 16 NOV 2023 STATES THAT THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS UNKNOWN. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER (CARWILD CORPORATION) FOR INVESTIGATION. CARWILD REPORTS: "THE INVESTIGATION WAS BASED ON THE REVIEW OF DHR, MANUFACTURING PROCEDURES, HISTORICAL COMPLAINT AND TRAINING RECORDS, AND NO FINDINGS WERE FOUND. NO SAMPLE WAS PROVIDED THEREFORE A PROPER INVESTIGATION CANNOT BE PERFORMED. NO CORRECTIVE ACTION WAS CONDUCTED." TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTED OF THIS NATURE. OTHER REMARKS: N/A. CORRECTED DATA: N/A.

    Description of Event or Problem · 0

    THE REPORT STATES, "OUR OR TEAM REPORTED THAT THESE SPONGES SHRED IN THE SURGICAL FIELD". AT THE TIME OF THIS REPORT THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

    Description of Event or Problem · 0

    THE REPORT STATES, "OUR OR TEAM REPORTED THAT THESE SPONGES SHRED IN THE SURGICAL FIELD". AT THE TIME OF THIS REPORT THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1619857 SPG RSEBD STRL XRAY FOAM 1/4" 200/BX GAUZE/SPONGE, INTERNAL, X-RAY GDY TELEFLEX MEDICAL 22D1300 04026704417681

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown