BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MELOLIN STERILE 20X10CM CTN 100

    MDR report key: 11813820 · Received May 12, 2021

    Report

    Report Number
    8043484-2021-01090
    Event Type
    Malfunction
    Date Received
    May 12, 2021
    Date of Event
    April 21, 2021
    Report Date
    September 1, 2021
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    NAC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MELOLIN STERILE 20X10CM CTN 100 PACKAGE, CAN NOT BE OPENED ASEPTICALLY, BECAUSE THE STERILE PART IS NOT SUFFICIENTLY INTEGRAL AND STRONG AND TEARS WHEN OPENED. NO CASE INVOLVED.

    Additional Manufacturer Narrative · 1

    SMITH & NEPHEW, INC. IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED UPON INFORMATION WHICH SMITH & NEPHEW, INC. HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, SMITH & NEPHEW, INC., OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT.

    Additional Manufacturer Narrative · 1

    THE DEVICE INTENDED TO BE USED IN TREATMENT HAS BEEN RETURNED AND EVALUATED ESTABLISHING A RELATIONSHIP WITH THE REPORTED EVENT. THE VISUAL INSPECTION REPORTED NO ISSUES, FUNCTIONAL ASSESSMENT CONFIRMED THEY WERE DIFFICULT TO OPEN. THE ROOT CAUSE WAS IDENTIFIED AS A GLUE FIRMNESS AND STORAGE ENVIRONMENT ISSUE. THE MANUFACTURING RECORDS SHOW NO EVIDENCE THAT THE PRODUCT DID NOT MEET SPECIFICATION AT THE TIME OF MANUFACTURE. THE COMPLAINT HISTORY FILE CONTAINS FURTHER INSTANCES. 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 A MELOLIN STERILE 20X10CM CTN 100 PACKAGE, CAN NOT BE OPENED ASEPTICALLY. NO CASE INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712113 MELOLIN STERILE 20X10CM CTN 100 MELOLIN STERILE 20X10CM CTN 100 NAC SMITH & NEPHEW MEDICAL LTD. 2032B

    Patients

    Seq Age Sex Outcome Treatment
    1