BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYPLAST COLLAGEN IMPLANT

    MDR report key: 201809 · Received December 10, 1998

    Report

    Report Number
    2939859-1998-00301
    Event Type
    Injury
    Date Received
    December 10, 1998
    Date of Event
    November 9, 1998
    Report Date
    November 11, 1998
    Manufacturer
    COLLAGEN CORP.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS IS THE SAME EVENT AND THE SAME PT REPORTED UNDER THE MDR ID # 2939859-1998-00300 (COLLAGEN CORP #1023785). THIS SECOND MDR IS BEING SUBMITTED FOR THE SECOND SUSPECT PRODUCT, ALSO A DEVICE MFG 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 BY ANOTHER PHYSICIAN IN 1997 (EXACT DATE NOT KNOWN) WITH NEGATIVE RESULTS. THE PT HAS REC'D MULTIPLE TREATMENTS SINCE WITHOUT EVENT. ON 13 JANUARY 1998, THE PT WAS FIRST TREATED BY THE REPORTING PHYSICIAN, WITHOUT EVENT. ON 9 NOVEMBER 1998, THE PT WAS TREATED WITH TWO FORMULATIONS OF PRODUCT IN THE NASOLABIAL FOLDS. ABOUT 3 HOURS AFTER THE TREATMENT, THE PT DEVELOPED REDNESS AT ALL THE TREATED SITES. THE PHYSICIAN EXAMINED THE PT ON 10 NOVEMBER 1998 AND NOTED REDNESS, SWELLING, AND HEAT TO THE TOUCH AT THE NASOLABIAL SITES. THE PT WAS GIVEN INTRAMUSCULAR CELESTONE, ORAL PREDNISONE AND CHLOR-TRIMENTON. THE PHYSICIAN DIAGNOSED THE SYMPTOMS AS HYPERSENSITIVITY RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZYPLAST COLLAGEN IMPLANT Implant GAX LMH COLLAGEN CORP. NA 98C262A

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention