BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLAPLUG

    MDR report key: 33111 · Received May 10, 1996

    Report

    Report Number
    2023141-1996-00002
    Event Type
    Injury
    Date Received
    May 10, 1996
    Date of Event
    April 11, 1996
    Report Date
    April 30, 1996
    Manufacturer
    INTEGRA LIFE SCIENCES
    Product Code
    LMF
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DR REPORTED THAT A WOUND DRESSING WAS IN PLACE IN AREA OF A THIRD MOLAR. PT DEVELOPED SORENESS AND WHAT SEEMED TO BE A SLIGHT INFECTION. DR INDICATED THAT INFECTION WAS POSSIBLY CAUSED FROM COMMUNICATION WITH THE SINUS. ANTIBIOTICS WERE GIVEN AND A DRAIN PLACED. DEVICE PLACED IN SITE OF TOOTH EXTRACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAPLUG Implant WOUND DRESSING LMF INTEGRA LIFE SCIENCES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention