BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEVYN LIFE M 12.9X12.9 CTN10

    MDR report key: 12370179 · Received August 26, 2021

    Report

    Report Number
    8043484-2021-01697
    Event Type
    Injury
    Date Received
    August 26, 2021
    Date of Event
    November 16, 2017
    Report Date
    November 11, 2021
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    NAD
    UDI-DI
    05000223478018
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    B5: LITERATURE CITATION: FORNI C, D'ALESSANDRO F, GALLERANI P, GENCO R, BOLZON A, BOMBINO C, MINI S, ROCCHEGIANI L, NOTARNICOLA T, VITULLI A, AMODEO A, CELLI G, TADDIA P. EFFECTIVENESS OF USING A NEW POLYURETHANE FOAM MULTI-LAYER DRESSING IN THE SACRAL AREA TO PREVENT THE ONSET OF PRESSURE ULCER IN THE ELDERLY WITH HIP FRACTURES: A PRAGMATIC RANDOMISED CONTROLLED TRIAL. INT WOUND J. 2018 JUN;15(3):383-390. DOI: 10.1111/IWJ.12875. EPUB 2018 JAN 4. PMID: 29314659; PMCID: PMC7950011. THE COMPLAINT WAS RECEIVED AS A RESULT OF ISSUES BEING IDENTIFIED IN A LITERATURE ARTICLE. DUE TO THIS, NO SPECIFIC PRODUCT DETAILS OR BATCH/LOT NUMBERS HAVE BEEN AVAILABLE TO THE INVESTIGATION. AS A RESULT OF THIS, NO DEVICE HISTORY REVIEW WAS POSSIBLE. A COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE PRODUCT FAMILY AND EVENT DESCRIPTION, THERE HAVE BEEN FURTHER INSTANCES IN THE PAST THREE YEARS. ACCORDING TO THE ARTICLE, THE DEVICES WERE BEING USED IN PATIENT TREATMENT. THE DEVICES USED FOR TREATMENT HAVE NOT BEEN RETURNED TO SMITH AND NEPHEW FOR ANALYSIS. WE HAVE THEREFORE NOT BEEN ABLE TO CONFIRM A RELATIONSHIP BETWEEN THE EVENT AND THE DEVICE OR IDENTIFY A DEFINITIVE ROOT CAUSE. NO RELEVANT SUPPORTING CLINICAL INFORMATION HAS BEEN PROVIDED TO ASSIST WITH A CLINICAL INVESTIGATION. THE PATIENT'S CURRENT CONDITION IS UNKNOWN AND THE PATIENT IMPACT BEYOND THE REPORTED EVENTS COULD NOT BE DETERMINED BASED ON THE LIMITED INFORMATION PROVIDED. THEREFORE, BASED ON INSUFFICIENT INFORMATION, A THOROUGH CLINICAL ASSESSMENT CANNOT BE PERFORMED AT THIS TIME. SHOULD ANY ADDITIONAL CLINICAL INFORMATION BE PROVIDED THIS COMPLAINT WILL BE RE-EVALUATED. THE MEDICAL REVIEW COULD NOT ESTABLISH A LINK BETWEEN THE PRODUCT AND HARM REPORTED WITHIN THIS COMPLAINT. USERS OF THE DEVICE ARE ADVISED TO CONSULT THE INSTRUCTIONS FOR USE, TO REDUCE FUTURE OCCURRENCES OF THE REPORTED ISSUE. THIS GUIDE PROVIDES COMPREHENSIVE INSTRUCTIONS OF THE OPERATION, USE AND LIMITATIONS OF THE DEVICE, INCLUDING ADVICE ON APPLICATION AND REMOVAL OF DRESSINGS. THIS INVESTIGATION HAS NOW BEEN CLOSED. NO FURTHER ACTIONS BY SMITH AND NEPHEW ARE DEEMED NECESSARY AT THIS STAGE. WE WILL CONTINUE TO MONITOR FOR ANY ADVERSE TRENDS RELATING TO ALL PRODUCT RANGES.

    Additional Manufacturer Narrative · 1

    INTERNAL REFERENCE NUMBER CASE (B)(4).

    Description of Event or Problem · 1

    ON THE LITERATURE ARTICLE NAME "EFFECTIVENESS OF USING A NEW POLYURETHANE FOAM MULTI-LAYER DRESSING IN THE SACRAL AREA TO PREVENT THE ONSET OF PRESSURE ULCER IN THE ELDERLY WITH HIP FRACTURES: A PRAGMATIC RANDOMISED CONTROLLED TRIAL", IT WAS REPORTED THAT, WHEN USING ALLEVYN LIFE M 12.9X12.9 CTN10 TO PREVENT THE ONSET OF PRESSURE ULCER IN ELDERLY PATIENTS WITH HIP FRACTURES, 6 PATIENTS SUFFERED A LEVEL 2 PRESSURE ULCER FORMATION. FURTHER INFORMATION ON HOW WAS THE TREATMENT CONCLUDED IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1267956 ALLEVYN LIFE M 12.9X12.9 CTN10 DRESSING,WOUND,OCCLUSIVE NAD SMITH & NEPHEW MEDICAL LTD. 66801068 UNKNOWN 05000223478018

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention