BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEVYN GENTLE 10CM X 10CM

    MDR report key: 10182063 · Received June 22, 2020

    Report

    Report Number
    8043484-2020-00910
    Event Type
    Malfunction
    Date Received
    June 22, 2020
    Date of Event
    May 29, 2020
    Report Date
    July 7, 2020
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    NAD
    UDI-DI
    05000223463427
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H10. ADDITIONAL INFORMATION RECEIVED FROM REPORTER HAS CONFIRMED THAT THE INCIDENT REPORTED IN THIS COMPLAINT IS THE SAME REPORTED UNDER COMPLAINT (B)(4), WITH MDR NO. 8043484-2020-00941. WE THEREFORE CLOSE THIS COMPLAINT AS A DUPLICATE. FURTHER COMMUNICATIONS AND RESULTS OF INVESTIGATION WILL BE SENT UNDER MDR NO. 8043484-2020-00941.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO ALLEVYN DRESSING BOXES FROM DIFFERENT SIZES AND BATCHES HAD A SILICONE OFFSET. ADDITIONALLY WHEN REMOVING A DRESSING FROM A PATIENT'S BOTTOM, SILICONE RESIDUE WAS LEFT ON THE PATIENT'S SKIN. THE DRESSING HAD ONLY BEEN IN SITU FOR A FEW HOURS. THE DRESSINGS WERE STORED APPROPRIATELY IN THE DRESSING CUPBOARD SO NOT NEAR ANY HEAT SOURCES. IT IS UNKNOWN IF THERE WAS A BACK-UP DRESSING AVAILABLE, AND IF THERE WAS A DELAY IN THE PROCEDURE. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645622 ALLEVYN GENTLE 10CM X 10CM DRESSING,WOUND,OCCLUSIVE NAD SMITH & NEPHEW MEDICAL LTD. 05000223463427

    Patients

    Seq Age Sex Outcome Treatment
    1