BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYDERM 2 COLLAGEN IMPLANT

    MDR report key: 193319 · Received October 21, 1998

    Report

    Report Number
    2939859-1998-00256
    Event Type
    Injury
    Date Received
    October 21, 1998
    Date of Event
    September 1, 1998
    Report Date
    October 13, 1998
    Manufacturer
    COLLAGEN CORP.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    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 SKIN TESTED IN 05/1998 WITH NEGATIVE RESULTS AND TREATED WITH TWO FORMULATIONS OF COLLAGEN IN 07/1998 INTO THE GLABELLA, NASOLABIAL AND PERIORAL AREAS. IN 09/1998, THE PT DEVELOPED GRANULOMAS AND INFLAMMATORY SYMPTOMS AT THE GLABELLA AND LEFT NASOLABIAL. IN 09/1998, THE PHYSICIAN PRESCRIBED CRYOTHERAPY AND INTRALESIONAL TRIAMCINOLONE, WHICH WERE NOT EFFECTIVE. THE SYMPTOMS WERE CONSIDERED PRODUCT RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZYDERM 2 COLLAGEN IMPLANT Implant INJECTABLE COLLAGEN IMPLANT LMH COLLAGEN CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention