BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLATAPE

    MDR report key: 266946 · Received March 3, 2000

    Report

    Report Number
    1121308-2000-00001
    Event Type
    Injury
    Date Received
    March 3, 2000
    Date of Event
    February 19, 1999
    Report Date
    February 4, 2000
    Manufacturer
    INTEGRA LIFESCIENCES
    Product Code
    LPG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INTEGRA LIFESCIENCES CORP WAS CONTACTED REGARDING THIS INCIDENT BY THE SPOUSE OF THE PATIENT IN QUESTION ON FEBRUARY 4, 2000. SURGERY WAS PERFORMED IN 1999 FOR REMOVAL OF A NASAL PALANTINE CYST. APPROXIMATELY 1 WEEK AFTER THE PROCEDURE THE ORAL SURGEON NOTED A WHITE MATERIAL EXTRUDED FROM THE SURGICAL SITE. THIS WHITE MATERIAL WAS NOT IDENTIFIED. THE PATIENT EXPERIENCED PAIN, AND IN 1999 UNDERWENT AN ADDITIONAL SURGERY AT THE SAME SITE, PERFORMED BY A DIFFERENT ORAL SURGEON. THIS SURGEON INDICATED THAT FIBROUS MATERIAL WAS REMOVED FROM THE SITE. THE PATIENT EXPERIENCED NO RELIEF FROM PAIN. IN 1999 A THIRD SURGERY WAS PERFORMED BY THE SECOND SURGEON, WHO INDICATED AMORPHOUS MATERIAL WAS REMOVED AND THE BONE APPEARED NORMAL. BIOPSY CONCLUDED DENSE SCAR TISSUE WAS PRESENT. PATIENT STILL EXPERIENCED NO RELIEF FROM THE PAIN. MARCAINE WAS INJECTED INTO THE SURGICAL SITE APPROXIMATELY ONE WEEK BEFORE THIS REPORT WAS RECEIVED BY INTEGRA LIFESCIENCES CORP. THIS RESULTED IN SOME PAIN RELIEF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLATAPE COLLAGEN WOUND DRESSING LPG INTEGRA LIFESCIENCES NA 8003400

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other