BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOOT STRAP ANKLE DSTRCTR STRL(6)

    MDR report key: 10759818 · Received October 29, 2020

    Report

    Report Number
    1219602-2020-01703
    Event Type
    Injury
    Date Received
    October 29, 2020
    Date of Event
    July 17, 2020
    Report Date
    March 15, 2022
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    KQZ
    UDI-DI
    03596010095329
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE: (B)(4). H3, H6: THE REPORTED DEVICE WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION, THUS VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THERE WAS NO WAY TO DETERMINE IF THE DEVICE CONTRIBUTED TO THE REPORTED EVENT. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED, AND THUS, A MANUFACTURING RECORD REVIEW COULD NOT BE CONDUCTED. A COMPLAINT HISTORY REVIEW CONCLUDED THIS WAS AN ISOLATED EVENT. THE INSTRUCTIONS FOR USE WAS REVIEWED AND FOUND TO INCLUDE CONDITIONS OF OFF LABEL USE AND TECHNIQUE SPECIFICS, AS WELL AS PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. PER SUBSEQUENT E-MAIL, NO RELEVANT CLINICAL INFORMATION NOT THE DEVICE WILL RETURN FOR INCLUSION IN THIS MEDICAL INVESTIGATION. THEREFORE, A THOROUGH MEDICAL INVESTIGATION CANNOT BE RENDERED. PER THE COMPLAINT DETAILS, THE PATIENT¿S OUTCOME IS UNKNOWN. THEREFORE, NO FURTHER CLINICAL/MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. THE COMPLAINT WAS NOT CONFIRMED. FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE IMPROPER PLACEMENT/ADJUSTMENT OF THE DEVICE OR AN ADVERSE BIOLOGICAL PATIENT REACTION TO THE DEVICE MATERIALS. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR RECOMMENDATIONS ON PROPER USE OF THE DEVICE AND POTENTIAL TROUBLESHOOTING METHODS TO PREVENT FUTURE REOCCURRENCE OF THE REPORTED EVENT. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED AT A FUTURE DATE, THIS INVESTIGATION WILL BE REOPENED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, AFTER A PROCEDURE WITH FOOT STRAP DISTRACTORS, THE PATIENT DEVELOPED SKIN INFLAMMATION. PATIENT'S OUTCOME IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1219228 FOOT STRAP ANKLE DSTRCTR STRL(6) COMPONENT, TRACTION, NON-INVASIVE KQZ SMITH & NEPHEW, INC. 014407 UNKNOWN 03596010095329

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other