BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYPLAST COLLAGEN IMPLANT (2.5ML)

    MDR report key: 312925 · Received January 18, 2001

    Report

    Report Number
    2939859-2001-00010
    Event Type
    Injury
    Date Received
    January 18, 2001
    Date of Event
    December 20, 2000
    Report Date
    December 21, 2000
    Manufacturer
    MCGHAN MEDICAL CORP.(FREMONT)
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS IS THE SAME EVENT AND THE SAME PT REPORTED UNDER MDR ID# 2939859-2001-00009 (MMC# 2000300). THIS IS THE SECOND MDR SUBMITTED FOR THE SECOND SUSPECT PRODUCT. HYPERSENSITIVITY INJECTION SITE. TREATED WITH MEDROL DOSE PACK AND BENADRYL CREAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2292 ZYPLAST COLLAGEN IMPLANT (2.5ML) INJECTABLE COLLAGEN IMPLANT LMH MCGHAN MEDICAL CORP.(FREMONT) 0923 00E081B

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention