BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYDERM 1 COLLAGEN IMPLANT (1.0ML)

    MDR report key: 322308 · Received March 23, 2001

    Report

    Report Number
    2939859-2001-00035
    Event Type
    Injury
    Date Received
    March 23, 2001
    Report Date
    March 6, 2001
    Manufacturer
    MCGHAN MEDICAL CORP.(FERMONT)
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS IS THE SAME EVENT AND SAME PATIENT REPORTED UNDER MDR ID #2399859-2001-00036. (MMC #2003075) THIS IS THE FIRST MDR SUBMITTED FOR THE FIRST SUSPECT PRODUCT. HYPERSENSITIVITY INJECTION SITE/POSITIVE SKIN TEST AFTER TREATMENT. TREATED WITH ORAL CLARITIN BY A PHYSICIAN OTHER THAN REPORTING PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13055 ZYDERM 1 COLLAGEN IMPLANT (1.0ML) INJECTABLE COLLAGEN IMPLANT LMH MCGHAN MEDICAL CORP.(FERMONT) 0915 00B101B

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention BREAST IMPLANTS.