BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ABSCESSION DRAINAGE CATHETER

    MDR report key: 3143034 · Received May 23, 2013

    Report

    Report Number
    1319211-2013-00069
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    ANGIODYNAMICS
    Product Code
    FGE
    PMA / PMN Number
    K060023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEFECTIVE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR A DEVICE EVAL. THE FIRM IS ATTEMPTING TO OBTAIN THE DEVICE. AN INVESTIGATION INTO THE ROOT CAUSE FOR PRODUCT PROBLEM IS CURRENTLY IN PROGRESS. A REVIEW OF THE LOT HISTORY RECORDS WAS PERFORMED FOR ANY DEVIATIONS. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE RESULTS OF THE DEVICE EVAL WILL BE SENT VIA A FOLLOW UP MEDWATCH. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED ON (B)(6) 2013, A PT OF UNK AGE AND GENDER PRESENTED FOR A PROCEDURE THAT INVOLVED A DRAINAGE CATHETER. IT WAS REPORTED THE CATHETER HAD FRACTURED INSIDE OF THE PT. THERE WAS NO REPORT OF PERMANENT HARM OR INJURY TO THE PT. IT IS UNK AT THIS TIME IF THE DISPOSABLE DEVICE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228536 TOTAL ABSCESSION DRAINAGE CATHETER DRAINAGE CATHETER FGE ANGIODYNAMICS

    Patients

    Seq Age Sex Outcome Treatment
    1