BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAGEN TAPE - HELITAPE 1 X 3 (2.5CM X 7.5CM)

    MDR report key: 3031013 · Received March 28, 2013

    Report

    Report Number
    2523190-2013-00016
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    January 31, 2013
    Report Date
    March 28, 2013
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    EKR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    DOCTOR REPORTS SHE HARVESTED TISSUE FROM PALATE AND COVERED THE SITE WITH HELITAPE. THE BLEEDING WAS CONTROLLED AT FIRST AND LOOKED GREAT. PATIENT CAME BACK EVERY SINGLE DAY THE FOLLOWING WEEK. THE SITE WOULD NOT HEAL AND GOT SEVERLY INFECTED. ON (B)(6) 2013 DOCTOR REPORTS SHE HAD HARVESTED CONNECTIVE TISSUE AS A GRAFT FOR ROOT COVERAGE ((B)(6) 2013) AND THE AREA WHERE GRAFT TISSUE WAS TAKEN BECAME INFECTED ((B)(6) 2013), NOT SEVERLY INFECTED. SHE TREATED THE PATIENT WITH ANTIBIOTICS AND DEBRIDEMENT OF THE INFECTED AREA AND WOUND HEALED BY (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127822 COLLAGEN TAPE - HELITAPE 1 X 3 (2.5CM X 7.5CM) M54 - ORAL SURGERY EKR INTEGRA YORK, PA INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR