BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYPLAST COLLAGEN IMPLANT

    MDR report key: 85790 · Received April 22, 1997

    Report

    Report Number
    2939859-1997-00087
    Event Type
    Injury
    Date Received
    April 22, 1997
    Date of Event
    July 16, 1993
    Report Date
    April 15, 1997
    Manufacturer
    COLLAGEN CORP.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 8/26/97, THE INJECTING PHYSICIAN BELIEVED THAT THE OPTIC NEURITIS AND MULTIPLE SCLEROSIS WERE PROBABLY NOT RELATED TO THE COLLAGEN.

    Description of Event or Problem · 1

    A PATIENT REPORTED SHE RECEIVED HER FIRST TREATMENT ON 7/16/93 INTO THE NASOLABIAL FOLDS. SHE IMMEDIATELY DEVELOPED BUMPS AT THE TREATMENT SITES WHICH SHE BELIEVED WAS THE COLLAGEN MATERIAL VISIBLE IN THE SKIN. THE BUMPS RESOLVED IN A FEW DAYS WITH GENTLE MASSAGE TO THE AREAS. A RETURN VISIT ON 8/13/1993 INDICATED NO COMPLICATIONS. IN APPROXIMATELY 8/1996, THE PATIENT DEVELOPED BLURRED VISION IN THE RIGHT EYE. BASED ON THE RESULTS OF AN MRI AND SPINAL TAP, A DIAGNOSIS OF MULTIPLE SCLEROSIS AND OPTIC NEURITIS WAS GIVEN. NO MEDICAL OR SURGICAL INTERVENTION WAS PRESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZYPLAST COLLAGEN IMPLANT Implant GAX LMH COLLAGEN CORP. NA 92F147

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Disability MULTIVITAMINS (UNK TO 4/15/1997), BETA-CAROTENE 1)