BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOSYN 0 VL 5X18 BGS - 25 D-TACH

    MDR report key: 517953 · Received March 26, 2004

    Report

    Report Number
    2648188-2004-00003
    Event Type
    Injury
    Date Received
    March 26, 2004
    Date of Event
    February 1, 2004
    Report Date
    February 25, 2004
    Manufacturer
    MANATI - USS
    Product Code
    GAM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY THE SUTUTRES USED FOR A SKIN CLOSURE CAME UNTIED AND THE WOUND OPENED CAUSING A DEHISCENCE. THE WOUND WAS RE-CLOSED WITHOUT FURTHER COMPLICATION. NO ADDITIONAL INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSYN 0 VL 5X18 BGS - 25 D-TACH ABSORBABLE SYNTHETIC SUTURE GAM MANATI - USS NA A2J783

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other