BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM (VOLUME/CONCENTRATION UNK)

    MDR report key: 1060239 · Received June 12, 2008

    Report

    Report Number
    3005113652-2008-00034
    Event Type
    Injury
    Date Received
    June 12, 2008
    Date of Event
    May 7, 2008
    Report Date
    May 12, 2008
    Manufacturer
    PRINGY
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER TREATMENT IN THE GLABELLAR AREA WITH JUVEDERM (UNK VOLUME), THE PT EXPERIENCED BLEEDING, SWELLING, AND PAIN. THE PT TOOK ASPIRIN FOR THE PAIN AND USED TOPICAL ALOE VERA AND ARNICA. FOLLOW UP WITH THE RN INJECTOR NOTES THAT THE INJECTOR RECOMMENDED THAT THE PT TAKE ORAL TYLENOL INSTEAD OF ASPIRIN FOR THE PAIN AND CONTINUE TO TREAT THE AREA WITH TOPICAL ALOE VERA AND ARNICA. THE PT SOUGHT THE CARE OF ANOTHER HEALTH CARE PROFESSIONAL AND FOLLOW UP WITH THE NON TREATING PHYSICIAN NOTES THAT THE PHYSICIAN DIAGNOSED HEMATOMA AND INFECTION OF THE TREATMENT SITE DUE TO POOR INJECTION TECHNIQUE. THE PHYSICIAN BELIEVED THE HEMATOMA WAS DUE TO THE INJECTOR HITTING A BLOOD VESSEL. THE PHYSICIAN HAD A CULTURE DONE OF THE INFECTED AREA AND PRESCRIBED ORAL OMNICEF. THE PHYSICIAN STATES THAT FOLLOW UP WITH THE PT WILL CONTINUE. ALLERGAN WILL CONTINUE TO FOLLOW UP WITH THE PHYSICIAN WHO WAS NOT THE INITIAL INJECTOR BUT WHO IS NOW CARING FOR THE PT. THE INJECTOR DID NOT HAVE THE LOT NUMBER AVAILABLE AND ALLERGAN WILL CONTINUE FOLLOW UP WITH THE INJECTOR TO OBTAIN THE LOT NUMBER OF THE SYRINGE USED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JUVEDERM (VOLUME/CONCENTRATION UNK) JUVEDERM LMH PRINGY NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention