BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYDERM 1 COLLAGEN IMPLANT

    MDR report key: 156275 · Received March 13, 1998

    Report

    Report Number
    2939859-1998-00076
    Event Type
    Injury
    Date Received
    March 13, 1998
    Date of Event
    January 2, 1996
    Report Date
    February 17, 1998
    Manufacturer
    COLLAGEN CORP.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A NURSE REPORTED A PT WHO WAS TREATED IN 12/1995 INTO THE HORIZONTAL FOREHEAD LINES. ON 2 JANUARY 1996, THE PT DEVELOPED ERYTHEMA, RAISED WHEAL AND PRURITUS AT THE TREATMENT SITES, WHICH WAS BELIEVED TO BE A TYPICAL HYPERSENSITIVITY. IN 8/1996, TOPICAL HYDROCORTISONE WAS PRESCRIBED. ON 17 FEBRUARY 1998, FOLLOW UP INFO WAS RECEIVED. CONTINUOUS ERYTHEMA PERSISTED A LONG ONE HORIZONTAL FOREHEAD LINE WITH OCCASIONAL PRURITUS WITH ALCOHOL INGESTION, STRESS, OR EXPOSURE TO HEAT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Disability