BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACK VAGINAL PREP SCRB + PNT

    MDR report key: 2451991 · Received January 24, 2012

    Report

    Report Number
    9612030-2012-00002
    Event Type
    Malfunction
    Date Received
    January 24, 2012
    Report Date
    January 11, 2012
    Manufacturer
    COVIDIEN
    Product Code
    EFQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 PREP SPONGE. THE CUSTOMER REPORTS THAT THE TIP OF THE SPONGE STICK CAME OFF IN THE PT'S VAGINA. THE TIP WAS MANUALLY REMOVED FROM THE PT. THE CUSTOMER FURTHER STATED THAT THERE WAS NO HARM OR CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PACK VAGINAL PREP SCRB + PNT PREP SPONGE EFQ COVIDIEN 41533 131490264

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK