BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STICK SPONGE PVP PAINT

    MDR report key: 2498621 · Received March 2, 2012

    Report

    Report Number
    9612030-2012-00015
    Event Type
    Malfunction
    Date Received
    March 2, 2012
    Report Date
    March 1, 2012
    Manufacturer
    COVIDIEN
    Product Code
    KXF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2012. 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) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A SPONGE PREB STICK. THE CUSTOMER REPORTS THE SPONGE WAS USED FOR VAGINAL PREP. THE NURSE WENT IN AND DID HER SCRUB FOR APPROXIMATELY ONE MINUTE, WHEN SHE WENT TO RETRACT THE SPONGE STICK, THE ONLY THING THAT REMAINED WAS THE STICK. THE DOCTOR REMOVED THE SPONGE WITH SPONGE FORCEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STICK SPONGE PVP PAINT SPONGE PREP STICK KXF COVIDIEN 41550 1K071

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK