BEUDAMED
    FDA Adverse Event Summary report: N

    WOUND RETRACTOR

    MDR report key: 2082175 · Received April 22, 2011

    Report

    Report Number
    2082175
    Date Received
    April 22, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 22, 2011
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GAD
    Report Source
    User Facility report
    Reporter Location
    OR, US

    Narratives

    Description of Event or Problem · 1

    WHEN THE BOX WAS OPENED STAFF NOTICED A SMALL, STRINGY SUBSTANCE, RED/BROWN IN COLOR ON THE OUTSIDE OF THE LUBRICANT PACKAGE. STAFF FELT THIS CONTAMINATED THE ENTIRE BOX AND IT WAS NOT USED.====================== MANUFACTURER RESPONSE FOR WOUND RETRACTOR, APPLIED MEDICAL======================NO RESPONSE TO MESSAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WOUND RETRACTOR RETRACTOR GAD APPLIED MEDICAL C8XX2N0NCE 1132890

    Patients

    Seq Age Sex Outcome Treatment
    1 *