BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN APPLICA IV100

    MDR report key: 11844915 · Received May 18, 2021

    Report

    Report Number
    8043484-2021-01153
    Event Type
    Injury
    Date Received
    May 18, 2021
    Date of Event
    April 30, 2021
    Report Date
    August 31, 2021
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    FPX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 AND SKIN PREPARATION AND TIME LEFT ON PATIENT. NO LOT/SERIAL NUMBER HAS BEEN PROVIDED, THEREFORE A REVIEW IS NOT POSSIBLE. A COMPLAINT HISTORY REVIEW FOUND OTHER RELATED EVENTS. 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, WAS CONDUCTED A RETROSPECTIVE POST MARKET CLINICAL FOLLOW UP ACTIVITY (PMCF) ON THE USE OF APPLICA IV100. IN WHICH, ONE PATIENT TREATED REPORTED THAT THE SKIN DRIES OUT QUICKLY. THIS ADVERSE EVENT WAS TREATED REMOVING THE DEVICE AND MOISTURIZING THE SKIN. THIS DATA COLLECTION ACTIVITY HAD BEEN DONE RETROSPECTIVELY AND ANONYMOUSLY; THEREFORE, THE OUTCOME OF THE PATIENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737614 UNKN APPLICA IV100 UNKN APPLICA IV100 FPX SMITH & NEPHEW MEDICAL LTD. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R