BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYPLAST COLLAGEN IMPLANT

    MDR report key: 126297 · Received October 10, 1997

    Report

    Report Number
    2939859-1997-00229
    Event Type
    Injury
    Date Received
    October 10, 1997
    Date of Event
    August 22, 1996
    Report Date
    August 21, 1997
    Manufacturer
    COLLAGEN CORP.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED A PT WHO WAS TREATED ON 8-21 1996 WITH TWO FORMULATIONS OF COLLAGEN INTO THE ORAL COMMISURES, NASOLABIAL FOLDS, PERIORBITAL LINES, GLABELLA, AND VERTICAL LINES ABOVE THE UPPER LIP. ON 8-22 1996, THE PT NOTED REDNESS AT THE ORAL COMMISSURE TREATMENT SITES WITH RESOLVED SPONTANEOUSLY ON APPROX 8-26 1996. FOLLOW UP INFO REC'D ON 8-211997 WAS THAT THE PT WAS SEEN ON 4-2 1997. THE SYMPTOMS HAD RESOLVED ON 1-29 1997; THE PHYSICIAN HAD PRESCRIBED ORAL BENADRYL. THE PHYSICIAN BELIEVED THAT THE SYMPTOMS PROBABLY REPRESENTED A HYPERSENSITIVITY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention