BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROFORE KIT ANKLE 18-25CM USA CASE 8

    MDR report key: 12968071 · Received December 9, 2021

    Report

    Report Number
    8043484-2021-02004
    Event Type
    Malfunction
    Date Received
    December 9, 2021
    Date of Event
    November 10, 2021
    Report Date
    January 21, 2022
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    FQM
    UDI-DI
    05000223411244
    PMA / PMN Number
    EXEMPT
    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 WAS NOT RETURNED FOR EVALUATION, IMAGES HAVE BEEN PROVIDED CONFIRMING THE REPORTED EVENT. EVALUATION OF THE SUPPLIED IMAGES CONFIRMS THE REPORTED EVENT, THE IMAGES CLEARLY SHOW THE COBAND LAYER STICKING TOGETHER, WHICH WOULD CAUSE DIFFICULTY IN APPLICATION ¿A DOCUMENTATION REVIEW HAS BEEN CONDUCTED, CONFIRMING PREVIOUS COMPLAINTS OF THIS NATURE, WITH CORRECTIVE ACTIONS ASSIGNED, WHICH ESTABLISHED AND INADEQUATE STANDARD OPERATING PROCEDURE AS THE ROOT CAUSE. 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. THIS INVESTIGATION IS NOW COMPLETE, WITH NO ADDITIONAL CORRECTIVE ACTIONS DEEMED NECESSARY.

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTER THAT PROFORE KIT ANKLE 18-25CM USA CASE 8 SEEMS TO BE STICKING TO ITSELF AND LOOPING CAUSING IT TO BE VERY DIFFICULT TO IMPOSSIBLE TO GET A ACCURATE COMPRESSION. AS THIS HAPPENED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTER THAT, (10) PROFORE KIT ANKLE 18-25CM USA CASE 8 SEEMS TO BE STICKING TO ITSELF AND LOOPING CAUSING IT TO BE VERY DIFFICULT TO IMPOSSIBLE TO GET A ACCURATE COMPRESSION. AS THIS HAPPENED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1866197 PROFORE KIT ANKLE 18-25CM USA CASE 8 BANDAGE, ELASTIC FQM SMITH & NEPHEW MEDICAL LTD. 66020016 1278048 05000223411244

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown