BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLAGUIDE COLLAGEN DENTAL MEMBRANE

    MDR report key: 2560311 · Received April 30, 2012

    Report

    Report Number
    2530154-2012-00006
    Event Type
    Injury
    Date Received
    April 30, 2012
    Report Date
    April 30, 2012
    Manufacturer
    KENSEY NASH CORP.
    Product Code
    NPL
    PMA / PMN Number
    K090919
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: ADD'L PRODUCT AND CLINICAL INFO HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    A PT IMPLANTED WITH COLLAGUIDE COLLAGEN DENTAL MEMBRANE HAD A POST-OPERATIVE INFECTION. THE TIME OF ONSET WAS NOT REPORTED. THE INFECTION WAS TREATED WITH ORAL AUGMENTIN AND CHLORHEXIDINE GLUCONATE RINSE TWO TIMES PER DAY. NO SURGICAL INTERVENTION WAS PERFORMED. THE INFECTION WAS NOT CONSIDERED TO BE SERIOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAGUIDE COLLAGEN DENTAL MEMBRANE NPL KENSEY NASH CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention