BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PILLING SPG NEURO STRL 3/4 X 3/4 200/BX

    MDR report key: 2844691 · Received November 9, 2012

    Report

    Report Number
    1044475-2012-00149
    Event Type
    Malfunction
    Date Received
    November 9, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 26, 2012
    Manufacturer
    TELEFLEX
    Product Code
    EFQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RECEIVED BY THE MANUFACTURER AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: ALLEGED ISSUE: CUSTOMER REPORTED THAT TINY BITS OF THREADS ARE COMING OFF THE SPONGES AND BEING LEFT INSIDE THE PATIENT. NO PATIENT INJURY REPORTED. PATIENT CURRENT CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PILLING SPG NEURO STRL 3/4 X 3/4 200/BX SPONGE EFQ TELEFLEX 09F1645

    Patients

    Seq Age Sex Outcome Treatment
    1