BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYPLAST COLLAGEN IMPLANT

    MDR report key: 208278 · Received January 29, 1999

    Report

    Report Number
    2939859-1999-00031
    Event Type
    Injury
    Date Received
    January 29, 1999
    Date of Event
    December 1, 1998
    Report Date
    January 11, 1999
    Manufacturer
    COLLAGEN CORP.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    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 PATIENT REPORTED SHE WAS SKIN TESTED IN JULY 1998 WITH A NEGATIVE RESULT. SHE RECEIVED TWO TREATMENTS IN AUGUST 1998 AND NOVEMBER 1998 (EXACT DATES UNKNOWN) WITH TWO FORMULATIONS OF COLLAGEN INTO THE NASOLABIAL FOLDS, GLABELLA, PERIORBITAL LINES BY A PHYSICIAN WHOSE NAME WAS REFUSED. IN DECEMBER 1998 (EXACT DATE UNKNOWN) THE PATIENT NOTICED "ARTHRITIC LIKE PAIN" DEVELOPED IN THE LOWER LIMBS. THE PATIENT WAS EXAMINED BY AN ORTHOPEDIST (NAME REFUSED) WHO DIAGNOSED MUSCLE SPASMS. VICODIN WAS PRESCRIBED. THE PATIENT DID NOT INFORM THE ORTHOPEDIST THAT SHE HAD BEEN TREATED WITH COLLAGEN. THE PATIENT HAD SCHEDULED AN APPOINTMENT ON 15 JANUARY 1999 WITH THE ORTHOPEDIST BECAUSE SYMPTOMS HAD WORSENED. THE PATIENT HAD NOT DECIDED WHETHER TO INFORM THE ORTHOPEDIST THAT SHE HAD BEEN TREATED WITH COLLAGEN. SHE HAD NOT INFORMED THE PHYSICIAN WHO TREATED HER WITH COLLAGEN ABOUT THESE SYMPTOMS. THE PATIENT DENIED ANY LOCAL SYMPTOMS AT THE TREATMENT SITES. THE PATIENT BELIEVED THE SYMPTOMS COULD POSSIBLY RELATED TO THE COLLAGEN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention 2. ESTRADERM PATCH (UNK TO 07/1998),| 3. FELDENE (UNK TO 07/1998),| 1. SYNTHROID (UNK TO 07/1998),| 4. MIACALCIN (UNK TO 07/1998).