BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROFORE 18-25CM ANKLE CIRC. CASE 8

    MDR report key: 12681119 · Received October 22, 2021

    Report

    Report Number
    8043484-2021-01905
    Event Type
    Malfunction
    Date Received
    October 22, 2021
    Date of Event
    October 4, 2021
    Report Date
    November 11, 2021
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    FQM
    UDI-DI
    05031844000746
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE DEVICE, USE IN TREATMENT, HAS BEEN RETURNED FOR EVALUATION, THERE WAS NO OBVIOUS VISUAL ISSUE, IMAGES HAVE BEEN REVIEWED CONFIRMING INDIVIDUAL LAYERS WERE TIGHTLY GLUED TO ONE ANOTHER, 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

    (B)(4). POSTAL CODE (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, THE 4TH LAYER OF TWO PROFORE 18-25CM ANKLE CIRC. CASE 8 IS VERY HARD TO PULL OUT AND TO ROLL ON PATIENTS¿ LEGS. EVENTUALLY THIS 4TH LAYER WAS TORN DUE TO CLINICIAN HAD TO USE FORCE TO PULL IT OUT. THE ADHESIVENESS OF 4TH LAYER IS VERY TIGHT COMPARES WITH OTHER BATCHES. CLINICIANS CONCERN THAT THIS MIGHT AFFECT THE COMPRESSION PRESSURE AND TREATMENT OUTCOMES. IT CONSUMES HUGE NURSING TIME AND MIGHT NOT ACHIEVE DESIRABLE COMPRESSION PRESSURE TOO. AS THESE WERE NOTICED DURING A SET UP OR INSPECTION, PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1579833 PROFORE 18-25CM ANKLE CIRC. CASE 8 BANDAGE, ELASTIC FQM SMITH & NEPHEW MEDICAL LTD. 66000016 1108350 05031844000746

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown