BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ABSCESSIN DRAINAGE CATHETER

    MDR report key: 3143035 · Received May 23, 2013

    Report

    Report Number
    1319211-2013-00071
    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 EVALUATION. 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 LOT MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE RESULTS OF THE DEVICE EVALUATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. COMPLAINT #(B)(4).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230229 TOTAL ABSCESSIN DRAINAGE CATHETER DRAINAGE CATHETER FGE ANGIODYNAMICS

    Patients

    Seq Age Sex Outcome Treatment
    1