BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-ARMOR DRAPE

    MDR report key: 15029673 · Received July 15, 2022

    Report

    Report Number
    2182318-2022-00083
    Event Type
    Malfunction
    Date Received
    July 15, 2022
    Report Date
    June 20, 2022
    Manufacturer
    TIDI PRODUCTS LLC
    Product Code
    KKX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    COMMON DEVICE NAME: PUI IS THE PRODUCT CODE FOR THIS DEVICE, HOWEVER, IT WAS NOT AVAILABLE IN THE PRODUCT CODE DROP DOWN DURING SUBMISSION OF THE REPORT. DEVICE EVALUATED BY MFR: DEVICE RETURN IS EXPECTED, BUT NOT YET RECEIVED. THERE IS NO LOT INFORMATION AVAILABLE, SO THE PRODUCT DEVICE HISTORY RECORD COULD NOT BE REVIEWED. HISTORICAL COMPLAINT DATA REVIEW IDENTIFIED NO OTHER SIMILAR COMPLAINTS FOR DAMAGED PACKAGING, RESULTING IN LOSS OF STERILITY DOCUMENTED FOR THIS SKU IN THE LAST 5 YEARS. AT THIS TIME, THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT. THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE NECESSARY. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS PART OF THIS MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED AND ACTED UPON AS WARRANT. MANUFACTURER REFERENCE FILE: (B)(4).

    Description of Event or Problem · 0

    REPORTED ISSUE: ONE WAS OUT OF THE WRAPPING AND THE CONTENTS WERE NO LONGER STERILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2371913 C-ARMOR DRAPE C-ARMOR DRAPES CLEAR POLYETHYLENE STERILE UNIVERSAL FIT KKX TIDI PRODUCTS LLC 5523 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown