BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYPLAST COLLAGEN IMPLANT

    MDR report key: 91257 · Received May 14, 1997

    Report

    Report Number
    2939859-1997-00116
    Event Type
    Injury
    Date Received
    May 14, 1997
    Date of Event
    August 11, 1996
    Report Date
    May 6, 1997
    Manufacturer
    COLLAGEN CORP.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PATIENT RECEIVED HIS SECOND TREATMENT ON 8/9/1996 INTO ACNE SCARS AT THE CHEEKS. ON 8/11/1996, THE PATIENT NOTED SYMPTOMS (TYPE UNKNOWN), AT A LEFT CHEEK TREATMENT SITE. ON 8/15/1996, THE PATIENT PRESENTED WITH A "CRUSTED EROSION" AT A LEFT CHEEK TREATMENT SITE. THE PHYSICIAN DIAGNOSED A NECROSIS; TOPICAL ERYTHROMYCIN WAS PRESCRIBED. ON 8/23/1996, THE PATIENT PRESENTED WITH PERSISTENT, BUT IMPROVED SYMPTOMS AT THE LEFT CHEEK TREATMENT SITE; NO ADDITIONAL INTERVENTION WAS PRESCRIBED. ON 5/6/1997, FOLLOW UP WAS RECEIVED; THE PATIENT WAS LAST SEEN ON 12/27/1996. THE SYMPTOMS RESOLVED IN 11/1996 WITH MILD, SLIGHT RESIDUAL SCARRING INDISTINGUISHABLE FROM ORIGINAL ACNE SCARS AND ADJACENT SCARS. NO FURTHER INTERVENTION WAS PRESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZYPLAST COLLAGEN IMPLANT Implant GAX LMH COLLAGEN CORP. NA 95M272A

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Disability