BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOOTPRINT PEEK 4.5 M

    MDR report key: 1962173 · Received January 17, 2011

    Report

    Report Number
    1219602-2011-00017
    Event Type
    Malfunction
    Date Received
    January 17, 2011
    Date of Event
    September 3, 2010
    Report Date
    December 17, 2010
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    METAL TIP OF THE HANDLE FOR THE SUTURE ANCHOR BROKE AND REMAINS INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOOTPRINT PEEK 4.5 M FOOTPRINT ULTRA PK SUTURE ANCHOR, 4.5 MBI SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE 72202901 50338023

    Patients

    Seq Age Sex Outcome Treatment
    1