BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYDERM 1 COLLAGEN IMPLANT

    MDR report key: 172837 · Received June 15, 1998

    Report

    Report Number
    2939859-1998-00145
    Event Type
    Injury
    Date Received
    June 15, 1998
    Date of Event
    April 23, 1998
    Report Date
    May 18, 1998
    Manufacturer
    COLLAGEN CORP.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN REPORTED THAT THE SYMPTOMS RESOLVED AS OF MARCH 1999.

    Description of Event or Problem · 1

    THIS IS THE SAME EVENT AND THE SAME PT REPORTED UNDER MDR ID #2939859-1998-00144. 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 ON 8 SEPTEMBER 1989 AND THEN 27 MAY 1997 WITH NEGATIVE RESULTS. THE PT HAS HAD MULTIPLE COLLAGEN TREATMENTS WITHOUT ADVERSE RESPONSE. ON 2 APRIL 1998, THE PT WAS TREATED WITH TWO FORMULATIONS OF COLLAGEN IN THE NASOLABIAL FOLDS AND ORAL COMMISURES. APPROX 3 WEEKS AFTER THE TREATMENT, THE PT DEVELOPED REDNESS, SWELLING, AND INDURATION AT ALL TREATMENT SITES. THE PHYSICIAN BELIEVED THE SYMPTOMS WERE A HYPERSENSITIVITY AND PRESCRIBED MOTRIN THREE TIMES A DAY. NO FURTHER MED OR SURGICAL INTERVENTION WAS PLANNED OR PRESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZYDERM 1 COLLAGEN IMPLANT Implant INJECTABLE COLLAGEN IMPLANT LMH COLLAGEN CORP. NA 97L081C

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention BOTOX (UNK TO 05/28/1998).