BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROFORE KIT LFF CASE 8

    MDR report key: 12574049 · Received October 5, 2021

    Report

    Report Number
    8043484-2021-01835
    Event Type
    Malfunction
    Date Received
    October 5, 2021
    Date of Event
    September 20, 2021
    Report Date
    November 9, 2021
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    FQM
    UDI-DI
    05031844013883
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE, USED IN TREATMENT, HAS BEEN RETURNED AND EVALUATED, THERE WAS NO OBVIOUS VISUAL ISSUE, HOWEVER, THE FUNCTIONAL EVALUATION CONFIRMED THE PROFORE LAYER 4 WAS DIFFICULT TO UNWIND. A RELATIONSHIP AGAINST THE REPORTED EVENT HAS BEEN ESTABLISHED. A COMPLAINT HISTORY REVIEW CONFIRMED FURTHER INSTANCES OF THIS NATURE. A REVIEW OF THE MANUFACTURING RECORDS CONFIRMED THE DEVICE WAS RELEASED ACCORDING TO SPECIFICATION. A FURTHER REVIEW OF THE MANUFACTURING PROCESS WAS ALSO PERFORMED, AND A ROOT CAUSE OF INADEQUATE STANDARD OPERATING PROCEDURE HAS BEEN ASSIGNED. CORRECTIVE ACTION HAS BEEN ASSIGNED REGARDING THIS EVENT TO REDUCE THE PROBABILITY OF FURTHER REOCCURRENCES. THIS INVESTIGATION IS NOW COMPLETE, SMITH + NEPHEW WILL CONTINUE TO MONITOR FOR ANY ADVERSE TRENDS RELATING TO THIS PRODUCT RANGE.

    Additional Manufacturer Narrative · 1

    INTERNAL REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING TREATMENT, THE FOURTH LAYER OF A PROFORE KIT LFF CASE 8 BECAME EXTREMELY DIFFICULT TO UNROLL WHEN GETTING DOWN TO THE LAST 1/4 OF THE ROLL. ONCE APART IT WAS STRETCHED OUT AND COULD NOT BE USED. TREATMENT WAS RESUMED, WITH A LESS THAN OR EQUAL TO 30 MINUTES DELAY, WITH A BACK-UP DEVICE. IT IS UNKNOWN IF THIS HAPPENED BEFORE, DURING OR AFTER TREATMENT. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1476921 PROFORE KIT LFF CASE 8 BANDAGE, ELASTIC FQM SMITH & NEPHEW MEDICAL LTD. 66020626 1244137 05031844013883

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown