BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 580560 · Received March 4, 2005

    Report

    Report Number
    2135225-2005-00003
    Event Type
    Other
    Date Received
    March 4, 2005
    Date of Event
    May 1, 2004
    Report Date
    March 3, 2005
    Manufacturer
    BIOFORM MEDICAL, INC.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    BIOFORM REC'D A LETTER FROM TEH FOOD AND DRUG ADMINISTRATION REQUESTING THAT CO INVESTIGATE A REPORT REC'D BY THE FDA THROUGH THE FDA MEDWATCH MED REPORTING PROGRAM. REFER TO ACCESS NUMBER MW4003865. A PT HAS HAD A PERMANENT LIP DISFIGUREMENT AS A RESULT OF FOUR RADIESSE INJECTIONS. PORTIONS OF THE INITIAL COMPLAINT HAVE BEEN OBLITERATED IN THE COPY PROVIDED TO BIO FORM MEDICAL, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * INJECTABLE IMPLANT LMH BIOFORM MEDICAL, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention