BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIPRO 0 30 BLUE C-17

    MDR report key: 1861838 · Received October 5, 2010

    Report

    Report Number
    2647580-2010-00818
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    August 27, 2010
    Report Date
    September 13, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GAW
    PMA / PMN Number
    K954808
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    PROCEDURE: SINEW RECONSTRUCTION. ACCORDING TO THE REPORTER: THE SURGERY HAPPENED ON (B)(6)2010. ON (B)(6)2010, SURGEON NOTICED AT A REEXAMINATION, THAT THE SUTURE DISSOLVED ITSELF. THE SURGEON HAD TO OPERATE AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGIPRO 0 30 BLUE C-17 NON-ABSORBABLE SUTURE PRODUCT GAW USSC PUERTO RICO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other