BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TCC-EZ CASE OF 10 CASTING SYSTEMS 3" NO BOOT

    MDR report key: 7509392 · Received May 11, 2018

    Report

    Report Number
    9680091-2018-00016
    Event Type
    Malfunction
    Date Received
    May 11, 2018
    Date of Event
    April 16, 2018
    Report Date
    April 17, 2018
    Manufacturer
    DERMA SCIENCES, INC.
    Product Code
    ITG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. OTHER MGF REPORT NUMBERS: 9680091-2018-00017.

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION WAS NOT RETURNED FOR EVALUATION. BATCH RECORD WAS REVIEWED AND THERE WERE NO DEVIATIONS FOUND IN THE PRODUCTION PROCESS OR IN THE FINISHED GOODS INSPECTION. RETAINED SAMPLE WAS PULLED OUT FOR ANALYSIS. FULL SPECIFICATION TESTING WAS DONE AND ALL PARAMETERS WERE FOUND TO BE ACCEPTABLE. THE PRODUCT WAS RELEASED WITHOUT ANY ISSUE.

    Description of Event or Problem · 1

    2 OF 2 REPORTS: IT WAS REPORTED THAT ON (B)(6) 2018, TCC23001 TCC-EZ CASE OF 10 CASTING SYSTEMS 3" NO BOOT WAS APPLIED ON A PATIENT BUT DID NOT SET UP CORRECTLY OR HARDEN UP. MULTIPLE CAST WAS APPLIED ON THE PATIENT UNTIL THEY FOUND ONE THAT HARDENED. THE PRODUCT PROBLEM CAUSED A TEN MINUTE DELAY IN THE PROCEDURE. HOWEVER, THE DELAY HAD NO IMPACT TO THE PATIENT'S CONDITION OR OUTCOME BESIDES THE ADDITIONAL TIME IN THE CLINIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349589 TCC-EZ CASE OF 10 CASTING SYSTEMS 3" NO BOOT TCC-EZ ITG DERMA SCIENCES, INC. 1017011

    Patients

    Seq Age Sex Outcome Treatment
    1