BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROFORE LITE SYSTEM KIT CASE 8

    MDR report key: 12892905 · Received November 30, 2021

    Report

    Report Number
    8043484-2021-01981
    Event Type
    Malfunction
    Date Received
    November 30, 2021
    Date of Event
    October 29, 2021
    Report Date
    December 29, 2021
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    FQM
    UDI-DI
    05031844002498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE DEVICE HAS NOT BEEN RETURNED FOR COMPLAINT EVALUATION. THE IMAGES SUPPLIED FOR REVIEW, DO NOT CLEARLY HIGHLIGHT THE REPORTED ISSUE, HOWEVER FOLLOWING A REVIEW OF THE MANUFACTURING PROCESS, WE ARE ABLE TO CONFIRM THE REPORTED COMPLAINT AND RELATE THE ISSUE TO A MANUFACTURING PROBLEM. A REVIEW OF THE MANUFACTURING RECORDS AND PROCESSES WAS PERFORMED, WITH A ROOT CAUSE OF INADEQUATE STANDARD OPERATING PROCEDURE ASSIGNED. A DOCUMENTATION REVIEW HAS BEEN CONDUCTED, CONFIRMING PREVIOUS COMPLAINTS OF THIS NATURE, WITH CORRECTIVE ACTIONS ASSIGNED AND COMPLETED. THE COMPLAINED PRODUCT WAS RELEASED PRIOR TO THE ACTIONS BEING IMITATED. THE INSTRUCTIONS FOR USE CONTAIN COMPREHENSIVE INSTRUCTIONS ON THE SAFE OPERATION AND USE OF THE DEVICE. THE RISK FILES MITIGATE THE REPORTED ISSUE WITH NO UPDATES REQUIRED. SMITH AND NEPHEW CAN CONFIRM THE DEVICE WAS RELEASED ACCORDING TO SPECIFICATIONS AND CONTINUE TO MONITOR FOR ADVERSE TRENDS RELATING TO THIS PRODUCT RANGE.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED, THE COBAN LAYER OF FIFTEEN (15) PROFORE LITE SYSTEM KIT CASE 8 ARE SO TIGHT IT'S VERY DIFFICULT TO GET A PROPER WRAP, THEREFORE, IS IMPACTING THE ABILITY TO USE. THIS PROBLEM WAS NOTICED BEFORE TREATMENT AND A BACK UP WAS AVAILABLE; THEREFORE, PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1792645 PROFORE LITE SYSTEM KIT CASE 8 BANDAGE, ELASTIC FQM SMITH & NEPHEW MEDICAL LTD. 66000415 1278046 05031844002498

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown