BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PILLING NEURO SPONGE 1X2" X 1/2"

    MDR report key: 1762955 · Received June 30, 2010

    Report

    Report Number
    1044475-2010-00071
    Event Type
    Malfunction
    Date Received
    June 30, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 8, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    EFQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE EVENT IS DESCRIBED AS: THE SPONGE DETERIORATES DURING SURGERY LEAVING PIECES OF LINT. THESE PIECES WERE PICKED OUT OF THE WOUND. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PILLING NEURO SPONGE 1X2" X 1/2" NEURO SPONGE EFQ TELEFLEX MEDICAL NA 09H2125

    Patients

    Seq Age Sex Outcome Treatment
    1