BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    90018107 LAP SPG P-W 18X18 NON-STR

    MDR report key: 1945274 · Received December 21, 2010

    Report

    Report Number
    1282497-2010-00023
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Report Date
    December 1, 2010
    Manufacturer
    GRAND MEDICAL
    Product Code
    GEL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2010. AN INVESTIGATION IS CURRENTLY UNDERWAY, UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2010 THAT A CUSTOMER HAD AN ISSUE WITH A LAP SPONGE. THE CUSTOMER REPORTED THAT THE LAP SPONGE UNRAVELED AND FRAYED. THIS WAS NOTICED DURING SURGERY BY THE PHYSICIAN/OPERATING ROOM SCRUB TECHNICIANS. ANY LOOSE THREADS WERE REMOVED FROM THE PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 90018107 LAP SPG P-W 18X18 NON-STR LAP SPONGE GEL GRAND MEDICAL 6822 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK