BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICAL PATTIE, 1/2 X 1/2

    MDR report key: 4954294 · Received July 30, 2015

    Report

    Report Number
    1226348-2015-10434
    Event Type
    Injury
    Date Received
    July 30, 2015
    Date of Event
    July 2, 2015
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    HBA
    PMA / PMN Number
    PK880402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THERE IS 200 PCS FOR 801400 (SURG PATTIES), HOWEVER,WHEN CUSTOMER OPEN THE OUTBOX AND FOUND THERE ARE ONLY 199 PCS INSIDE OF THIS PRODUCT. EVENT OCCURRED BEFORE SURGERY, NO DELAYS. BACKUP PRODUCT USED TO COMPLETE PROCEDURE. THE PRODUCT WAS SENT ON (B)(4) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497454 SURGICAL PATTIE, 1/2 X 1/2 SURGICAL SPONGE HBA CODMAN & SHURTLEFF, INC. 614649

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention