BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICAL PATTIE 1/2 X 1/2

    MDR report key: 3696331 · Received March 24, 2014

    Report

    Report Number
    1226348-2014-11330
    Event Type
    Injury
    Date Received
    March 24, 2014
    Date of Event
    March 10, 2014
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    FQA
    PMA / PMN Number
    PK880402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 WILL BE REVIEWED. WE ANTICIPATE THAT THE EVALUATION WILL REVEAL THAT THE DEVICE CONFORMED TO SPECIFICATIONS PRIOR TO RELEASE. IF ANYTHING OTHERWISE IS FOUND THEN A FOLLOW UP REPORT WILL BE FILED. IF AT SOME POINT THE DEVICE DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED: NO PROCEDURE. DURING SET UP, THE PACKAGE SAID 10 ITEMS BUT THEY COUNTED THEM AND IT WAS ONLY 9. PRODUCT WAS DISCARDED. NO PHOTOS AVAILABLE. NO PATIENT INVOLVED. NO FURTHER INFORMATION AVAILABLE. THE PRODUCT WAS DISCARDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173080 SURGICAL PATTIE 1/2 X 1/2 SURGICAL SPONGE FQA CODMAN & SHURTLEFF, INC. 415307

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention