BEUDAMED
    FDA Adverse Event Other Summary report: N

    RIGID INJECTION NEEDLE - STRAIGHT

    MDR report key: 1006495 · Received March 3, 2008

    Report

    Report Number
    2135225-2008-00010
    Event Type
    Other
    Date Received
    March 3, 2008
    Date of Event
    January 17, 2008
    Report Date
    February 29, 2008
    Manufacturer
    BIOFORM MEDICAL, INC.
    Product Code
    GAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A FOLLOW-UP WITH THE HOSPITAL, IT WAS REPORTED THAT THE PATIENT HAS NOT REPORTED ANY DISCOMFORT OF ISSUES WITH THE DISPLACEMENT OF THE NEEDLE TIP. THE DEVICE WAS RETURNED TO BIOFORM MEDICAL, INC. FOR EVALUATION. THE NEEDLE CANNULA HAD BEEN BENT IN A C-SHAPED ARC AND THE TIP WAS NOT RECOVERED. VISUAL INSPECTION OF THE CANNULA REVEALED DRIED RADIESSE IN THE NEEDLE HUB AND CANNULA TIP. THE BREAKAGE HAD OCCURRED AT THE WELD JUNCTURE. REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED LOT 1005588, MET ALL SPECIFICATIONS. UPON REVIEW OF THE FDA MEDICAL DEVICE REPORT DECISION TREE AT BIOFORM MEDICAL INC., 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

    LISTED BELOW IS A SUMMARY OF THE EVENT REPORTED BY A REP FROM A HOSPITAL, TO THE FDA IN 2008. DURING A RADIESSE VOCAL CORD INJECTION, THE RIGID VOCAL INJECTION NEEDLE TIP BROKE AND COULD NOT BE RECOVERED. A BRONCHOSCOPY AND NECK AND CHEST X-RAYS WERE CONDUCTED WITHOUT RECOVERY OF THE NEEDLE TIP. THE PATIENT HAS NOT EXPERIENCED DISCOMFORT OR PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIGID INJECTION NEEDLE - STRAIGHT INJECTION NEEDLE GAA BIOFORM MEDICAL, INC. 1005588

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other