BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYPLAST COLLAGEN IMPLANT

    MDR report key: 252832 · Received December 6, 1999

    Report

    Report Number
    2939859-1999-00249
    Event Type
    Injury
    Date Received
    December 6, 1999
    Date of Event
    June 21, 1999
    Report Date
    September 29, 1999
    Manufacturer
    COLLAGEN CORP.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS IS THE SAME EVENT AND THE SAME PT REPORTED UNDER MDR ID #2939859-1999-00246 (COLLAGEN CORP #1025577). THIS SECOND MDR IS BEING SUBMITTED FOR THE SECOND SUSPECT PRODUCT, ALSO A DEVICE MANUFACTURED BY COLLAGEN CORP. THIS SEPARATE DISTINCT NUMBER IS PROVIDED PER THE FDA'S REQUEST FOR TRACEABILITY PURPOSES. A PHYSICIAN REPORTED A PT WHO WAS ORIGINALLY SKIN TESTED ON 5/14/99 AND RETESTED ON 6/7/99, BOTH WITH NEGATIVE RESULTS. IN 1999, THE PT WAS TREATED WITH TWO FORMULATIONS OF PRODUCT IN THE NASOLABIAL FOLDS. ON 7/9/99, THE PT PHONED THE OFFICE AND REPORTED REDNESS AND SWELLING AT ALL THE TREATMENT SITES. THE PT STATED THE SYMPTOMS BEGAN ON 6/21/99. SHE DENIED HARDNESS OR ITCHING. THE PHYSICIAN BELIEVED THE SYMPTOMS WERE PROBABLY HYPERSENSITIVITY RELATED TO THE COLLAGEN. ON 7/9/99, THE PHYSICIAN PRESCRIBED ORAL PREDNISONE FOR 5 DAYS WHICH WAS NOT VERY EFFECTIVE. ON 8/23/99, RESULTS OF A BACTERIAL CULTURE OF THE RIGHT CHEEK SITE INDICATED STAPHYLOCOCCUS AUREUS. ON 9/7/99, THE PHYSICIAN PRESCRIBED CIPRO FOR INFECTION WHICH WAS EFFECTIVE. THE PT WAS LAST EXAMINED THE WEEK OF 11/1/99. THE PHYSICIAN NOTED "PUS" AND REDNESS THAT REOCCURS INTERMITTENTLY AT THE TREATMENT SITES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZYPLAST COLLAGEN IMPLANT Implant INJECTABLE COLLAGEN IMPLANT LMH COLLAGEN CORP. NA 98M101H

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention