BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURG PAT XRAY 1/2X1/2

    MDR report key: 3099549 · Received May 8, 2013

    Report

    Report Number
    1226348-2013-16737
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 18, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    FQA
    PMA / PMN Number
    PK880402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. SINCE A LOT NUMBER HAS BEEN PROVIDED A REVIEW OF THE MANUFACTURING RECORDS HAVE BEEN CONDUCTED AND THEY REVEALED THAT THE DEVICE CONFORMED TO ALL MANUFACTURING AND QUALITY TESTING/INSPECTION SPECIFICATIONS PRIOR TO BEING RELEASED TO STOCK. IF AT SOME POINT THE DEVICE IS RETURNED FOR EVALUATION THIS COMPLAINT WILL BE RE-OPENED AND INVESTIGATED. BASED ON THIS EVALUATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED. PLEASE NOTE THAT A THERAPY DATE HAS BEEN SPECIFIED AS IT IS A REQUIRED FIELD. WE DO NOT USE THERAPY DATES AND AS A RESULT TODAY'S DATE WAS USED. (B)(4): DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    THE REP REPORTED THAT THE PATTIE WAS MISPLACED DURING THE SURGERY, HOWEVER, WHEN LOCATED THE DEVICE WAS X-RAYED AND COULD NOT BE SEEN UNDER XRAY. IN ADDITION A DEVICE FROM ANOTHER LOT, NOT USED IN THE CASE WAS ALSO XRAYED AND COULD NOT BE SEEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201703 SURG PAT XRAY 1/2X1/2 SURGICAL SPONGE FQA CODMAN & SHURTLEFF, INC. 184407

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention (B)(4)