BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN AWM PRODUCT

    MDR report key: 10047581 · Received May 12, 2020

    Report

    Report Number
    8043484-2020-00432
    Event Type
    Injury
    Date Received
    May 12, 2020
    Date of Event
    February 24, 2020
    Report Date
    August 4, 2020
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    KGX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE DEVICE, USED IN TREATMENT, HAS NOT BEEN RETURNED, HOWEVER PHOTOS HAVE BEEN PROVIDED ESTABLISHING A RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT REPORTED. CLINICAL INVESTIGATION REPORTS, THE SUPPLIED PHOTOS PROVIDED HAVE BEEN REVIEWED AND ASSESSED. THE TREATMENT THERAPY DELIVERED INCLUDING THE TOPICAL CREAM AND BARRIER SPRAY REPORTEDLY RESOLVED THE MACERATION, EXCORIATION, AND THE EXUDATE THAT WAS LEAKING FROM DRESSING. GIVEN THAT THE REMEDIES FOR TREATMENT ON THE WOUND AREA RESOLVED THE ISSUES NO FURTHER CLINICAL ASSESSMENT IS WARRANTED AT THIS TIME. THE IFU HAS BEEN REVIEWED, WHICH CONTAINS ADEQUATE WARNINGS/CAUTIONS IN RELATION TO THE USE, INCLUDING IF SENSITIZATION OR REDDENING OCCURS, TO STOP USING THE PRODUCT, HOWEVER CLINICAL DECISION IN THE USE OF THE PRODUCT SHOULD DEPICT NECESSARY TREATMENT, INCLUDING THE SELECTION OF THE MOST APPROPRIATE SIZE DRESSING ACCORDING TO NEEDS. A RISK MANAGEMENT REVIEW CONDUCTED PRODUCED SEVERAL FAILURE MODES THAT LEAD TO MECHANICAL DERMATOSES INCLUDING BUT NOT LIMITED TO; POOR REMOVAL TECHNIQUE, DRESSING APPLIED TO FRAGILE / SENSITIVE SKIN, INCREASED ADHESION, TRAUMA ON REMOVAL. WITHOUT SUPPORTING INFORMATION THIS FAILURE MODE CANNOT BE NARROWED DOWN ANY FURTHER. A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE AS NOT BATCH/LOT DETAILS HAVE BEEN PROVIDED, HOWEVER AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. COMPLAINT EVENT HISTORY FOR THE REPORTED EVENT HAS BEEN REVIEWED, REVEALING FURTHER INSTANCES. WE HAVE BEEN UNABLE TO DETERMINE A ROOT CAUSE ON THIS OCCASION. NO FURTHER ACTIONS BY SMITH AND NEPHEW ARE DEEMED NECESSARY AT THIS STAGE. HOWEVER, WE WILL CONTINUE TO MONITOR FOR ANY ADVERSE TRENDS RELATING TO THIS PRODUCT RANGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED EXCORIATION TO SURROUNDING SKIN WITHIN DRESSING. THIS EVENT WAS TREATED WITH BETNOVATE RD TOPICALLY AND IT WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511091 UNKNOWN AWM PRODUCT TAPE AND BANDAGE, ADHESIVE KGX SMITH & NEPHEW MEDICAL LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1