BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 1132024 · Received August 20, 2008

    Report

    Report Number
    2135225-2008-00047
    Event Type
    Injury
    Date Received
    August 20, 2008
    Date of Event
    July 30, 2008
    Report Date
    August 20, 2008
    Manufacturer
    BIOFORM MEDICAL
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A FOLLOW-UP WITH THE PHYSICIAN, SHE DID NOT FEEL BIOPSY WOULD BE NECESSARY AT THIS TIME, SINCE THE PATIENT'S SYMPTOMS WERE RESOLVING WITHOUT SCARRING. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED RADIESSE DERMAL FILLER LOT 1009347, HAS MET ALL SPECIFICATIONS.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED A PATIENT WHO HAD BEEN INJECTED WITH RADIESSE DERMAL FILLER IN THE NASO LABIAL FOLDS IN 2008. THE PATIENT HAD DEVELOPED SWELLING ON BOTH SIDES AND FINE BLISTERING ALONG ENTIRE LENGTH OF LEFT NFG WITHOUT PRESENTING NEURALGIA. THE PHYSICIAN PRESCRIBED MEDROL DOSE PACK AND LEVAQUIN (ANTIBIOTICS) THE FOLLOWING MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH BIOFORM MEDICAL 1009347

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention