BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYPLAST COLLAGEN IMPLANT

    MDR report key: 39206 · Received September 20, 1996

    Report

    Report Number
    2939859-1996-00039
    Event Type
    Injury
    Date Received
    September 20, 1996
    Date of Event
    September 10, 1996
    Report Date
    September 14, 1996
    Manufacturer
    COLLAGEN CORPORATION
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON 3 JULY 1997, FOLLOW UP INFO WAS RECEIVED FROM THE PHYSICIAN. THE PHYSICIAN HAD A TELEPHONE INTERVIEW WITH THE PT ON 22 JUNE 1997. ALL SYMPTOMS RESOLVED WITHIN 5-7 DAYS; THE ONLY ONGOING SYMPTOM WAS LOCAL DERMAL ATROPHY. THE PHYSICIAN'S ADDRESS HAS BEEN CHANGED.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED A PT WHO RECEIVED HER FIFTH TREATMENT ON 9/10/96 INTO THE UPPER AND LOWER VERMILION AND VERMILION BORDERS AND ORAL COMMISSURES. IMMEDIATELY AFTER THE TREATMENT, THE PHYSICIAN NOTED GOOD CORRECTION AT ALL SITES, SWELLING RELATED TO THE INJECTION PROCEDURE, AND A SUBTLE, DIFFUSE VIOLACEOUS HUE AT THE RIGHT UPPER VERMILION BORDER BETWEEN THE PHILTRUM AND THE RIGHT NASOLABIAL FOLD. ONCE THE NERVE BLOCK WORE OFF, THE PT EXPERIENCED SIGNIFICANT PAIN AT THE LIP INJECTION SITES. THAT EVENING, THE VERMILION AND CUTANEOUS PART OF THE RIGHT VERMILION BORDER BECAME MILDLY DUSKY, BELIEVED TO BE POSSIBLY RELATED TO VASOCONSTRICTION FROM THE NERVE BLOCK. IT WAS GONE BY THAT NIGHT OR THE NEXT DAY. FROM 9/10/96 TO 9/13/96, THE PT HAD PERSISTENT SWELLING AND PAIN AT THE TREATMENT SITES. ON 9/13/96, THE PHYSICIAN PRESCRIBED PREDNISONE; THE PT DID NOT FILL THE PRESCRIPTION. THE NIGHT OF 9/13/96, THE PT NOTED THE ONSET OF A SUBTLE DISCOLORATION AT THE RIGHT CUTANEOUS PORTION OF THE UPPER VERMILION BORDER; ON 9/14/96, THE DISCOLORATION BECAME MORE APPARENT. THE PHYSICIAN NOTED WISHBONE-SHAPED VIOLACEOUS PURPLISH-RED STREAKS WITH INDURATION AT THE CUTANEOUS PORTION OF THE RIGHT UPPER VERMILION BORDER EXTENDING TO THE SKIN ABOVE THE BORDER APPROX 1.5CM IN LENGTH. THE STREAKS APPEARED TO ORIGINATE FROM THE VERMILION BORDER UPWARD TOWARD THE RIGHT NASOLABIAL FOLD. HE ALSO NOTED A LINEAR AREA OF DISCOLORATION AT THE TREATMENT SITE BETWEEN THE PHILTRUM AND THE RIGHT NASOLABIAL FOLD. THERE WAS NO EVIDENCE OF TISSUE BREAKDOWN OR EROSION AT THE RIGHT VERMILION BORDER. THE SWELLING AT THE LEFT UPPER LIP AND ENTIRE LOWER LIP HAD IMPROVED ABOUT 30% FROM THE TIME OF THE INITIAL TREATMENT. HE ALSO NOTED AT THE CENTER OF THE UPPER LIP INJECTION SITE ON THE MUCOSAL SIDE INFERIOR TO THE PHRENULUM, A ROUND 6 X 8 MM DUSKY AREA WITH A CRUST ABOUT 2CM AWAY FROM THE WISHBONE-SHAPED AREA OF DISCOLORATION; HE BELIEVED THIS WAS RELATED TO A VASCULAR COMPROMISE. ON 9/15/96, THE WISHBONE-SHAPED DISCOLRATION HAD DECREASED IN INTENSITY DUE TO THE CELESTONE. THE PT TOOK 60 MG PREDISONE ON 9/15/96 AND DEVELOPED EMOTIONAL LABILITY RELATED TO THE CORTISONE, NOT RELATED TO THE COLLAGEN. THE PREDNISONE DOSE WAS HELD ON 9/16/96. THE PHYSICIAN BELIEVED THE SWELLING AT THE DISCOLORED AREA BETWEEN THE PHILTRUM AND THE RIGHT NASOLABIAL FOLD CONTRIBUTED TO A PARTIAL COMPROMISE OF A BLOOD VESSEL; HE WAS NOT SURE IF THE COMPROMISE WAS RELATED TO THE PRESENCE OF THE MATERIAL, TO EDEMA RELATED TO INJECTION PROCEDURE WHICH WAS SLOW TO RESOLVE, TO A VASOSPASM, OR TO A HYPERSENSITIVITY. HE DOUBTED IT WAS RELATED TO AN OCCLUSION OF A BLOOD VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZYPLAST COLLAGEN IMPLANT Implant GAX LMH COLLAGEN CORPORATION NA 96D077B,95F158D

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention MAXIDE (UNK TO 9/18/96)| WELLBUTRIN (9/12/96 TO 9/18/96)| LIDOCAINE W/EPINEPHRINE (9/10/96 TO 9/10/96)| PROCARDIA (TO 9/18/96)