BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAX GR 5X18 T16 3/0 DT

    MDR report key: 1409489 · Received June 30, 2009

    Report

    Report Number
    9681850-2009-00006
    Event Type
    Injury
    Date Received
    June 30, 2009
    Date of Event
    June 9, 2009
    Report Date
    June 12, 2009
    Manufacturer
    GOSPORT-USS
    Product Code
    GAN
    PMA / PMN Number
    K990951
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: SKIN CLOSURE. ACCORDING TO THE REPORTER: SUBCUTANEOUS SUTURE WAS USED ON THE LOWER LEG FOR SKIN CLOSURE. FOUR DAYS POST-OPERATION, THE SUTURE UNRAVELED AND SUTURE SITE OPENED. RE-OPERATION WAS REQUIRED TO FIX IT. PATIENT IS UNDER OBSERVATION, NO OTHER PATIENT INFO IS AVAILABLE. THERE WAS NO ADDITIONAL BLEEDING, OPERATING TIME WAS NOT EXTENDED, AND NOTHING FELL INTO THE CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAX GR 5X18 T16 3/0 DT ABSORBABLE MAXON SUTURE GAN GOSPORT-USS E8J0579C

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention