BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIDI PRODUCTS, LLC GRIP-LOK

    MDR report key: 12602467 · Received October 9, 2021

    Report

    Report Number
    2182318-2021-00011
    Event Type
    Malfunction
    Date Received
    October 9, 2021
    Date of Event
    July 1, 2021
    Report Date
    September 8, 2021
    Product Code
    KMK
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT WAS NOT RETURNED FOR EVALUATION. THIS REPORT IS BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER. FURTHER INFORMATION REGARDING THE USE OF THIS DEVICE IS NOT AVAILABLE FOR ANALYSIS. NO ANOMALIES OR NONCONFORMANCES WERE NOTED IN THE DEVICE HISTORY RECORD OF THIS LOT WHICH COULD HAVE CONTRIBUTED TO THIS EVENT. HISTORICAL COMPLAINT DATA WAS REVIEWED AND FOUND ONE OTHER SIMILAR COMPLAINT FOR THIS PART.. THIS COMPLAINT WAS RECEIVED OVER 2 YEARS AGO FOR THE COMPLAINT OF DEVICE NOT STICKING; SUBSEQUENTLY PULLING, CAUSING PAIN AND SLIGHT BLEEDING. THE NORMALIZE RATE OF THIS TYPE OF COMPLAINT IS (B)(4) FOR THESE PRODUCTS. THE CUSTOMER'S NOTE THAT, "MOISTURE DECREASES LIFE EXPECTANCY" SUGGESTS THAT THE DEVICE INSTRUCTIONS FOR USE MAY NOT HAVE BEEN FOLLOWED COMPLETELY. AS A PRECAUTION, REFRESHER IN-SERVICE TRAINING HAS BEEN PERFORMED WITH THE STAFF, WITH THE FOCUS AROUND PROPER SKIN PREP AND PLACEMENT IN EFFORT TO PREVENT THESE ISSUES FROM OCCURRING AGAIN. 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. (B)(4).

    Description of Event or Problem · 0

    OVER THE PAST LITTLE WHILE SOME PATIENTS EXPERIENCING TEARS TO THE URETHRAL. STAFF FINDING PRODUCT NOT STICKING TO THE LEG AND/OR NOT STAYING LONG. MOISTURE DECREASES LIFE EXPECTANCY. A SECOND DEVICE WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1500087 TIDI PRODUCTS, LLC GRIP-LOK FOLEY SECUREMENT DEVICE WITH ADHESIVE KMK 3400LFC 45258376

    Patients

    Seq Age Sex Outcome Treatment
    1