BEUDAMED
    FDA Adverse Event Other Summary report: N

    RIGID INJECTION NEEDLE - STRAIGHT

    MDR report key: 1014111 · Received March 13, 2008

    Report

    Report Number
    2135225-2008-00015
    Event Type
    Other
    Date Received
    March 13, 2008
    Date of Event
    February 26, 2008
    Report Date
    March 12, 2008
    Manufacturer
    BIOFORM MEDICAL, INC.
    Product Code
    GAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVAL OF THE DEVICE INDICATED THE NEEDLE TIP BROKE OFF FROM THE CANNULA AT THE WELD JUNCTURE. THE CANNULA WAS RETURNED VERY STRAIGHT AND HAD NOT BEEN USED. IT APPEARS THERE WAS A POSSIBLE LACK OF LATERAL STRENGTH CAUSING THE WELD TO BE INSUFFICIENT. BOTH THE CANNULA AND BROKEN NEEDLE TIP WERE PRESENT IN THE PACKAGE WHEN IT WAS OPENED PRIOR TO THE PROCEDURE. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED LOT 1008185, MET ALL SPECIFICATIONS. UPON REVIEW OF THE FDA MEDICAL DEVICE REPORT DECISION TREES AT BIOFORM MEDICAL, A DECISION WAS MADE TO REPORT THIS EVENT BASED ON THE CHANCE OF CAUSING INJURY IF THE EVENT WERE TO RECUR.

    Description of Event or Problem · 1

    DURING PREPARATION FOR A RADIESSE VOCAL FOLD INJECTION PROCEDURE, IT WAS REPORTED THAT WHEN THE PACKAGE CONTAINING THE VOCAL NEEDLE WAS OPENED, THE TIP WAS BROKEN OFF FROM THE CANNULA. THE INJECTION NEEDLE WAS UNABLE TO BE USED. SINCE THE EVENT OCCURRED OUTSIDE THE PT, THERE WAS NO PT INVOLVEMENT REPORTED WITH THE DEVICE BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIGID INJECTION NEEDLE - STRAIGHT INJECTION NEEDLE (VOCAL) GAA BIOFORM MEDICAL, INC. 1008185

    Patients

    Seq Age Sex Outcome Treatment
    1 Other