BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEMBRANE

    MDR report key: 33113 · Received April 24, 1996

    Report

    Report Number
    2023141-1996-00001
    Event Type
    Injury
    Date Received
    April 24, 1996
    Date of Event
    March 8, 1996
    Report Date
    April 8, 1996
    Manufacturer
    INTEGRA LIFE SCIENCES
    Product Code
    NPK
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    INFECTION AT SITE OF MEMBRANE PLACEMENT. ANTIBIOTICS WERE USED FOR A TWO WEEK PERIOD. THE SITE IS HEALING WELL. DR STATED THAT THE INFECTION COULD HAVE BEEN CONTRIBUTED TO BY ANY OF THE PRODUCTS USED DURING THE PROCEDURE. TREATMENT WITH ANTIBIOTICS 3/8/96 THROUGH 3/22/96.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEMBRANE MEMBRANE NPK INTEGRA LIFE SCIENCES NA 5003511

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention