BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYDERM COLLAGEN IMPLANT

    MDR report key: 96088 · Received June 4, 1997

    Report

    Report Number
    2939859-1997-00143
    Event Type
    Injury
    Date Received
    June 4, 1997
    Date of Event
    May 16, 1997
    Report Date
    May 29, 1997
    Manufacturer
    COLLAGEN CORP.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THAT A PATIENT WAS DOUBLE SKIN TESTED IN THE FOREARMS ON 04/19/1997 AND 05/02/1997. SHE RECEIVED HER FIRST TREATMENT WITH TWO FORMULATIONS OF COLLAGEN ON 05/15/1997 IN THE GLABELLA, NASOLABIAL FOLDS AND PERIORBITALLINES. ON 05/16/1997, THE PATIENT DEVELOPED REDNESS AND SWELLING AT ONE OF THE SKIN TEST SITES; SHE WAS SEEN ON 05/19/1997; THE PHYSICIAN INSTRUCTED THE PATIENT TO CONTINUE AMPICILLIN SHE WAS TAKING FOR AN UNRELATED CONDITION. ON 05/27/1997, THE PATIENT DEVELOPED REDNESS AND SWELLING AT THE GLABELLA. ON 05/29/1997, THE PATIENT PRESENTED WITH PERSISTENT SYMPTOMS; THE PHYSICIAN DIAGNOSED A HYPERSENSITIVITY. THE PHYSICIAN PRESCRIBED ZYRTEC AND EXPRESSED MATERIAL FROM THE TEST SITE BUT WAS UNSURE IF THE MATERIAL WAS PUS OR COLLAGEN. ON 06/02/1197, THE PATIENT PRESENTED WITH PERSISTENT SYMPTOMS; ATARAX WAS PRESCRIBED. ON 06/02/1997, ALL TREATMENT SITES WERE RED, SWOLLEN AND ITCHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZYDERM COLLAGEN IMPLANT Implant INJECTABLE COLLAGEN IMPLANT LMH COLLAGEN CORP. NA 96D080

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention AMPICILLIN (1997 TO 05/29/1997).