BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYDERM 2 COLLAGEN IMPLANT

    MDR report key: 239092 · Received September 3, 1999

    Report

    Report Number
    2939859-1999-00190
    Event Type
    Injury
    Date Received
    September 3, 1999
    Date of Event
    July 13, 1999
    Report Date
    August 12, 1999
    Manufacturer
    COLLAGEN CORP
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED A PT WHO ON 1/15/1999 WAS INITIALLY SKIN TESTED AT THE LEFT FOREARM, WITH NEGATIVE RESULTS. ON 5/14/1999 THE PT WAS FIRST TREATED AT THE NASOLABIAL FOLDS AND THE GLABELLA. THE PROCEDURE WAS WITHOUT EVENT. ON 7/31/1999 THE PT CALLED THE OFFICE TO REPORT ERYTHEMA, EDEMA, AND PALPABLE BUMPS AT THE TREATMENT SITES. THE PT STATED THE SYMPTOMS WERE INTERMITTENT. ON 7/14/1999 THE PT WAS EXAMINED AND THE PHYSICIAN NOTED MILD ERYTHEMA, AND INDURATION AT THE TREATMENT SITES. THE PHYSICIAN DIAGNOSED HYPERSENSITIVITY, AND RECOMMENDED THE PT MASSAGE THE SITES AND TAKE ORAL BENADRYL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZYDERM 2 COLLAGEN IMPLANT Implant INJECTABLE COLLAGEN IMPLANT LMH COLLAGEN CORP NA 98L141C

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention VITAMINS (UNK TO 5/14/1999).| PREMARIN (UNK TO 5/14/1999),| DYAZIDE (UNK TO 5/14/1999),| ISOPTIN (UNK TO 5/14/1999),