BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA PLUS

    MDR report key: 2220195 · Received August 9, 2011

    Report

    Report Number
    3005113652-2011-00057
    Event Type
    Injury
    Date Received
    August 9, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 12, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: BATCH NUMBER HV30637911 WAS RELEASED BY QC ACCORDING TO DEFINED SPECS. THE DOCUMENTARY RESEARCH IN THE BATCH FILE SHOWS THAT NO ELEMENT COULD EXPLAIN THESE REACTIONS: ALL THE MFG STEPS AND ALL THE PHYSICOCHEMICAL AND MICROBIOLOGICAL RESULTS (ENDOTOXINS, BIOBURDEN) ARE REGISTERED AS CONFORMING TO THE SPECS. THE STERILIZATION CYCLE IS REGISTERED AS CONFORMING. THE ATTRIBUTABILITY IS THEN IMPOSSIBLE TO DETERMINE.

    Description of Event or Problem · 1

    AN ALLERGAN REP, ON BEHALF OF A PHYSICIAN, INITIALLY REPORTED THAT IMMEDIATELY AFTER INJECTION IN THE NASOLABIAL FOLDS WITH JUVEDERM ULTRA PLUS THE PT DEVELOPED "NECROSIS AND BLANCHING" IN THE NASOLABIAL FOLDS UP TO THE NOSE AREA. THE PT WAS INJECTED WITH HYALURONIDASE ON THE SAME DATE. FURTHER F/U RECEIVED FROM THE TREATING PHYSICIAN STATES THAT THE PT EXPERIENCED SOME IMMEDIATE BLANCHING IN THE RIGHT NASOLABIAL FOLD WITH SOME BRUISING, BUT NO NECROSIS WAS OBSERVED BY THE TREATING PHYSICIAN. THE PT WAS INJECTED WITH 200 UNITS OF HYALURONIDASE THE SAME DAY AS THE JUVEDERM INJECTION. THE PT CAME BACK TO THE TREATING PHYSICIAN'S OFFICE LATER THE SAME DAY WITH SOME BLOTCHINESS TO THE RIGHT NASOLABIAL FOLD AND THE PHYSICIAN INJECTED ANOTHER 200 UNITS OF HYALURONIDASE. THE SYMPTOMS RESOLVED COMPLETELY 2 DAYS AFTER THE INITIAL JUVEDERM INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JUVEDERM ULTRA PLUS LMH ALLERGAN NA HV30637911

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention