BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYDERM COLLAGEN IMPLANT II

    MDR report key: 41820 · Received October 8, 1996

    Report

    Report Number
    2939859-1996-00048
    Event Type
    Injury
    Date Received
    October 8, 1996
    Date of Event
    September 15, 1996
    Report Date
    October 1, 1996
    Manufacturer
    COLLAGEN CORPORATION
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON 4/14/97, FOLLOW UP WAS RECEIVED: THE PATIENT WAS LAST SEEN ON 3/6/97; THE SYMPTOMS HAD RESOLVED ON 1/23/97.

    Description of Event or Problem · 1

    PT RECEIVED HER SECOND TREATMENT ON 8/28/96 WITH TWO FORMULATIONS OF COLLAGEN INTO THE HORIZONTAL FOREHEAD LINES, GLABELLA, NASOLABIAL FOLDS, AND UPPER AND LOWER LIPS; IT WAS UNKNOWN IF THE VERMILION OR VERMILION BORDER WAS INJECTED. ON 9/16/96, THE PT WAS NOT HAPPY WITH THE RESULTS OF THE TREATMENT; WHEN SEEN THAT DAY, SHE HAD LITTLE RAISED BEADS AT THE HORIZONTAL FOREHEAD LINES WHICH THE PHYSICIAN BELIEVED WAS THE COLLAGEN MATERIAL. THE EXACT DATE OIF ONSET OF THE BEADS WAS UNKNOWN. WARM COMPRESSES AND MASSAGE WERE PRESCRIBED. ON 9/26/96, THE PT TELEPHONED THE OFFICE AND REPORTED THAT THE TREATED AREAS WERE "GETTING WORSE". ON 9/30/96, SHE WAS SEEN WITH RAISED, RED WELTS WITHOUT INDURATION AT THE HORIZONTAL FOREHEAD LINES AND PINK, RAISED WELTS AT THE NASOLABIAL FOLDS. THE PHYSICIAN DIAGNOSED A HYPERSENITIVITY AND PRESCRIBED ORAL PREDNISONE IN A TAPERING DOSE, ORAL ATARAX, AND A TOPICAL CORTISONE CREAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZYDERM COLLAGEN IMPLANT II Implant INJECTABLE COLLAGEN IMPLANT LMH COLLAGEN CORPORATION NA 96D084

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention TRIAM