BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIANT DISPOSABLE PENCIL

    MDR report key: 3023384 · Received February 26, 2013

    Report

    Report Number
    1717344-2013-00107
    Event Type
    Malfunction
    Date Received
    February 26, 2013
    Date of Event
    May 20, 2012
    Report Date
    January 30, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVAL. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PENCIL REMAINED ACTIVE WHEN THE SURGEON WAS NOT DEPRESSING THE BUTTON. NO PT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83492 RELIANT DISPOSABLE PENCIL ES ACCESSORY GEI COVIDIEN LP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK