BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN PROFORE

    MDR report key: 12013805 · Received June 16, 2021

    Report

    Report Number
    8043484-2021-01504
    Event Type
    Injury
    Date Received
    June 16, 2021
    Date of Event
    February 10, 2000
    Report Date
    September 27, 2021
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    FQM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE DEVICE, USED IN TREATMENT, WAS NOT RETURNED FOR EVALUATION. ALL PROVIDED INFORMATION HAS BEEN REVIEWED AND WE HAVE NOT BEEN ABLE TO ESTABLISH A RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED EVENT OR DETERMINE A ROOT CAUSE. PROBABLE CAUSES MAY INCLUDE, APPLICATION, REMOVAL, TIME LEFT ON PATIENT, TRAUMA, MATERIALS USED WITHIN THE DRESSING. THE INSTRUCTIONS FOR USE PROVIDE COMPREHENSIVE INSTRUCTIONS OF THE OPERATION, USE AND LIMITATIONS OF THE DEVICE. THE ASSOCIATED RISK FILES CONTAIN DETAILS RELATING TO HARM. HOWEVER, THE CLINICAL REVIEW HAS NOT ESTABLISHED A CAUSAL LINK. NO LOT/SERIAL NUMBER HAS BEEN PROVIDED THEREFORE A REVIEW OF MANUFACTURING RECORDS IS NOT POSSIBLE. A COMPLAINT HISTORY REVIEW FOUND OTHER RELATED EVENTS. THIS INVESTIGATION IS NOW COMPLETE WITH NO FURTHER ACTION DEEMED NECESSARY. SMITH + NEPHEW WILL CONTINUE TO MONITOR FOR ANY ADVERSE TRENDS RELATING TO THIS PRODUCT RANGE. H6: UPDATED CODES.

    Description of Event or Problem · 1

    ON THE LITERATURE ARTICLE NAMED "RANDOMISED TRIAL COMPARING TWO FOUR-LAYER BANDAGE SYSTEMS IN THE MANAGEMENT OF CHRONIC LEG ULCERATION", IT WAS REPORTED THAT 13 PATIENTS EXPERIENCED ADVERSE EVENTS ASSOCIATED TO PROFORE USE. 1 OF THOSE PATIENTS EXPERIENCED SKIN IRRITATION AND NEW ULCERATION. NO ADDITIONAL INFORMATION ON POSSIBLE TREATMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907055 UNKN PROFORE BANDAGE, ELASTIC FQM SMITH & NEPHEW MEDICAL LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R