BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN SURGICAL PATTIE

    MDR report key: 3552157 · Received January 6, 2014

    Report

    Report Number
    1226348-2014-10189
    Event Type
    Injury
    Date Received
    January 6, 2014
    Date of Event
    December 5, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    HBA
    PMA / PMN Number
    PK880402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE BE ADVISED THAT PER THE NEW MATRIX ON 12/06/2013, THIS EVENT IS BEING CLASSIFIED AS A SERIOUS INJURY. 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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THAT (B)(4), OPENED A NEW 80-1404 BOX BEFORE HANDING OVER TO A HOSPITAL AND FOUND THAT THERE WERE ONLY 19 PACKAGES INSTEAD OF 20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7278 CODMAN SURGICAL PATTIE PADDIE, COTTONOID HBA CODMAN & SHURTLEFF, INC. 394767

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention