BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYPLAST COLLAGEN IMPLANT

    MDR report key: 218305 · Received March 30, 1999

    Report

    Report Number
    2939859-1999-00079
    Event Type
    Injury
    Date Received
    March 30, 1999
    Date of Event
    April 3, 1998
    Report Date
    March 1, 1999
    Manufacturer
    COLLAGEN CORP.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS IS THE SAME EVENT AND THE SAME PT REPORTED UNDER MDR ID # 2939859-1999-00078 (COLLAGEN CORP # 1023227). 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 PT REPORTED THAT SHE WAS FIRST TREATED SOME TIME BETWEEN 1983 AND 1988; THE DATES WERE NOT RECALLED. THE PT WAS DOUBLE SKIN TESTED IN 02/1998 AND 03/1998 WITH NEGATIVE RESULTS. ON 3 APRIL 1998, THE PT WAS TREATED WITH TWO FORMULATIONS OF PRODUCT IN THE GLABELLA, FOREHEAD, PERIORBITAL CROW'S FEET, JAWLINE, UNDER THE CHIN, IN A SMALL HORIZONTAL LINE UNDER THE NOSE, VERMILION BORDERS AND THE NASOLABIAL AREAS. AFTER TREATMENT, THE PT NOTED REDNESS IN THE NASOLABIALS. THE SYMPTOM DID NOT RESOLVE. WITHIN ONE MONTH OF TREATMENT, THE PT DEVELOPED REDNESS, SWELLING AND INDURATION AT THE PERIORBITAL AREA AND GLABELLA; THERE WAS REDNESS AND SWELLING AT BOTH FOREARM TEST SITES. THE PHYSICIAN DIAGNOSED A HYPERSENSITIVITY AND PRESCRIBED TOPICAL LIDEX-E AND ACLOVATE CREAMS. THE PT ALSO REPORTED SWELLING AND PAIN IN THE JOINTS OF HER HANDS AND KNEES. OVER THE SUMMER OF 1998, THE PT HAD EPISODES OF MYALGIAS AND ARTHRALGIAS, AS WELL AS CUTANEOUS SYMPTOMS OF THE LE CONSISTING OF ERYTHEMA AND SWELLING. A DIAGNOSIS OF LUPUS ER CONSISTING OF ERYTHEMA AND SWELLING. A DIAGNOSIS OF `LUPUS LIKE SYNDROME' WAS GIVEN. ORAL NSAIDS WERE PRESCRIBED. ON 29 DECEMBER 1998, THE SYMPTOMS AT THE TREATMENT SITES PERSISTED. ON 26 MARCH 1999, THE INJECTING PHYSICIAN DID NOT KNOW IF THE SYSTEMIC SYMPTOMS WERE RELATED TO THE COLLAGEN. THE RHEUMATOLOGIST BELIEVED IT WAS POSSIBLE THAT THE SYSTEMIC SYMPTOMS COULD BE RELATED TO COLLAGEN OR TO SILICONE BREAST IMPLANTS. FURTHER INFO FROM THE RHEUMATOLOGIST WAS DECLINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZYPLAST COLLAGEN IMPLANT Implant GAX LMH COLLAGEN CORP. NA 97H021A

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention SILICONE BREAST IMPLANT(S) (1974 TO 03/1999).| HORMONE REPLACEMENT THERAPY (UNK TO 03/1999),