BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIDI PRODUCTS, LLC GRIP-LOK

    MDR report key: 13120414 · Received December 30, 2021

    Report

    Report Number
    2182318-2021-00015
    Event Type
    Malfunction
    Date Received
    December 30, 2021
    Manufacturer
    TIDI PRODUCTS LLC
    Product Code
    KMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT WAS NOT RETURNED FOR EVALUATION. THIS REPORT IS BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER. MULTIPLE ATTEMPTS WERE MADE REQUESTING ADDITIONAL COMPLAINT INFORMATION. WITHOUT THE RETURN OF THE DEVICE NOR ADDITIONAL INFORMATION REGARDING THE EVENT, THE ROOT CAUSE COULD NOT BE DETERMINED. THE LOT NUMBER WAS NOT PROVIDED. THEREFORE, THE DEVICE HISTORY RECORD FOR THIS LOT COULD NOT BE REVIEWED. HISTORICAL COMPLAINT DATA WAS REVIEWED AND FOUND NO OTHER SIMILAR COMPLAINTS FOR THIS PART. SIMILAR COMPLAINTS RECEIVED FOR OTHER PRODUCTS WITHIN THIS PRODUCT FAMILY ARE NOT COMMON AND ARE OFTEN FROM NEW CUSTOMERS OR PEOPLE USING THE DEVICE FOR THE FIRST TIME. AT THIS TIME, THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT, AND THE INSTRUCTIONS FOR USE (IFU) 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 AT PRESENT. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY CADENCE. AS PART OF THIS MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED, AND ACTED UPON AS APPROPRIATE. MANUFACTURER REFERENCE FILE # (B)(4).

    Description of Event or Problem · 0

    1 IN 4 GRIP-LOKS STAY ON SKIN FOR 1 DAYS AND MANY PEEL OFF IN A FEW HOURS. LACK OF STICKINESS/ADHESIVE. NO SAMPLES OR LOT INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2019999 TIDI PRODUCTS, LLC GRIP-LOK GRIP-LOK SECUREMENT DEVICE FOR SMALL UNIVERSAL CATHETER KMK TIDI PRODUCTS LLC 3200S

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown