BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYLAFORM PLUS

    MDR report key: 586252 · Received March 28, 2005

    Report

    Report Number
    2246315-2005-00028
    Event Type
    Injury
    Date Received
    March 28, 2005
    Date of Event
    February 24, 2005
    Report Date
    February 28, 2005
    Manufacturer
    GENZYME BIOSURGERY
    Product Code
    LMH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED FROM A PHYSICIAN IN FEB 2005 REGARDING A PT WITH A HISTORY SINCE 2001 OF BOVINE COLLAGEN INJECTIONS (WITH NO ADVERSE EFFECTS), NO KNOWN ALLERGIES AND NO HISTORY OF AUTOIMMUNE DISEASE, WHO RECEIVED INJECTIONS OF HYLAFORM PLUS IN FEB 2005 TO THE NASOLABIAL FOLDS, MARIONETTE LINES AND PERIORAL LINES. TWO WEEKS LATER, THE INJECTION PT EXPERIENCED SWELLING AT INJECTION SITES; REDNESS AT INJECTION SITES; INDURATION AT INJECTION SITES; PRURITUS AT INJECTION SITE FOUR DAYS LATER PHYSICIAN EXAMINED THE PT AND DIAGNOSED AN ALLERGIC REACTION; ORAL PREDNISONE AND TOPICAL PANDEL CREAM (DOSES AND ONSET DATES NOT PROVIDED) WERE PRESCRIBED. AT THE TIME OF THE REPORT, THE PT HAD NOT YET RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYLAFORM PLUS DERMAL IMPLANT FOR AESTHETIC USE LMH GENZYME BIOSURGERY NA W0408

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention