BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRIP-LOK

    MDR report key: 7963862 · Received October 14, 2018

    Report

    Report Number
    2182318-2018-00016
    Event Type
    Injury
    Date Received
    October 14, 2018
    Report Date
    September 19, 2018
    Manufacturer
    TIDI PRODUCTS, LLC
    Product Code
    KMK
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT REQUESTED FOR RETURN BUT WILL NOT BE RETURNED. NO EVIDENCE WAS PROVIDED. THIS COMPLAINT IS BASED SOLELY ON CUSTOMER REPORTED ISSUE. ADHESIVE SUPPLIER WAS CONTACTED, THERE HAVE BEEN NO CHANGES IN PRODUCT FORMULATIONS. THERE IS NOT ENOUGH EVIDENCE TO ESTABLISH THE ROOT CAUSE OF THE SKIN IRRITATION AND REDNESS. BIOCOMPATIBILITY RESULTS FOR THIS SECUREMENT DEVICE FOUND SENSITIVITY LEVELS FOR SKIN CONTACT TO BE NEGLIGIBLE. INSTRUCTIONS FOR USE WERE REVIEWED AND DETERMINED TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR THE SAFE AND EFFECTIVE USE OF THE DEVICE. 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 WARRANTED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED ITCHING AND REDNESS ON THE SKIN OF PATIENT. THE DATE OF THE INCIDENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804401 GRIP-LOK GRIP-LOK MEDIUM WIDE ADHESIVE BULK NON-STERILE KMK TIDI PRODUCTS, LLC 3300MWA-NSB 24950354

    Patients

    Seq Age Sex Outcome Treatment
    1 Other