BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRA® JARIT®

    MDR report key: 8703375 · Received June 17, 2019

    Report

    Report Number
    8703375
    Event Type
    Malfunction
    Date Received
    June 17, 2019
    Date of Event
    June 4, 2019
    Report Date
    June 13, 2019
    Manufacturer
    INTEGRA YORK PA, INC.
    Product Code
    HRQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    2 CASES HAVE BEEN REPORTED REGARDING CONCERN FOR NEW KOCHER CLAMPS PURCHASED BY THE HOSPITAL. IN BOTH CASES, STAFF REPORT WHEN APPLYING THE KOCHER CLAMP TO THE FASCIA, THE CLAMP SLICED THROUGH THE FASCIA, TEARING THE TISSUE. MANUFACTURER RESPONSE FOR SURGICAL CLAMP, JARIT (PER SITE REPORTER). THE VENDOR HAS BEEN ON SITE TO VIEW THE CLAMPS BUT NO RESPONSE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499238 INTEGRA® JARIT® HEMOSTAT HRQ INTEGRA YORK PA, INC. 107-220 101707-1810

    Patients

    Seq Age Sex Outcome Treatment
    1 12045 DA