BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYPLAST COLLAGEN IMPLANT

    MDR report key: 198327 · Received November 19, 1998

    Report

    Report Number
    2939859-1998-00285
    Event Type
    Injury
    Date Received
    November 19, 1998
    Date of Event
    January 1, 1998
    Report Date
    October 26, 1998
    Manufacturer
    COLLAGEN CORP.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID # 2939859-1998-00284 (COLLAGEN CORPORATION #1023681). THIS SECOND MDR IS BEING SUBMITTED FOR THE SECOND SUSPECT PRODUCT, ALSO A DEVICE MANUFACTURED BY COLLAGEN CORPORATION. THIS SEPARATE DISTINCT NUMBER IS PROVIDED PER THE FDA'S REQUEST FOR TRACEABILITY PURPOSES. A PHYSICIAN REPORTED A PATIENT WHO WAS TREATED ON 30 SEPTEMBER 1998, INTO THE NASOLABIALS AND ACNE SCARS ON THE CHIN. THE PATIENT RETURNED ON 7 OCTOBER 1998 WITH ALL TREATMENT SITES RED WITH A FEW NODULES THAT WERE VERY RED; EXACT ONSET DATE UNKNOWN. THE PHYSICIAN INJECTED THE NODULES WITH INTRALESIONAL KENALOG, WHICH IMPROVED THE SYMTOMS SOMEWHAT. ON 26 OCTOBER 1998, THE PHYSICIAN OBSERVED MORE REDNESS AT THE TREATED SITES. THE PHYSICIAN PLANNED TO INJECT MORE KENALOG AND TO PRESCRIBE ORAL ANTIHISTAMINES. THE PHYSICIAN DIAGNOSED THE SYMPTOMS AS A HYPERSENSITIVITY RELATED TO COLLAGEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZYPLAST COLLAGEN IMPLANT Implant GAX LMH COLLAGEN CORP. NA 97K021

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention ADVIL (UNK TO 10/26/1998).