BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCRYL+ UD 27IN 3-0 S/A PS-2 PRM MP

    MDR report key: 20322088 · Received September 27, 2024

    Report

    Report Number
    2210968-2024-10357
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Date of Event
    January 1, 2024
    Report Date
    September 27, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031046511
    PMA / PMN Number
    K050845
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H3 INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. ONE SUTURE THAT PERTAIN TO PRODUCT CODE MCP427H WAS RECEIVED FOR ANALYSIS. UPON VISUAL ASSESSMENT OF THE RETURNED SAMPLE, IT WAS OBSERVED THAT THE STRAND HAD BEGUN WITH A DEGRADATION PROCESS CAUSED BY EXPOSURE TO THE ENVIRONMENT. IN ADDITION, THE NEEDLE AND FOIL WERE NOT RETURNED FOR EVALUATION. THIS PRODUCT CODE CONTAINS AN ABSORBABLE SUTURE. SINCE THE SAMPLE WAS RECEIVED OPEN, THE FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO UNDETERMINED EXPOSURE TIME TO THE ENVIRONMENT. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. AS PART OF THE ETHICON QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE MANUFACTURING RECORDS COULDN'T BE REVIEWED AS THE BATCH NUMBER IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE WAS RECEIVED WITH NO COMPLAINT INFORMATION. ATTEMPTS WERE MADE TO RECONCILE THE DEVICE WITH NO SUCCESS RESULTING IN THE CREATION OF A NEW COMPLAINT. UPON VISUAL ASSESSMENT OF THE RETURNED SAMPLE, IT WAS OBSERVED THAT THE STRAND HAD BEGUN WITH A DEGRADATION PROCESS CAUSED BY EXPOSURE TO THE ENVIRONMENT. IN ADDITION, THE NEEDLE AND FOIL WERE NOT RETURNED FOR EVALUATION. THIS PRODUCT CODE CONTAINS AN ABSORBABLE SUTURE. SINCE THE SAMPLE WAS RECEIVED OPEN, THE FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO UNDETERMINED EXPOSURE TIME TO THE ENVIRONMENT. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1492286 MCRYL+ UD 27IN 3-0 S/A PS-2 PRM MP SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. 10705031046511

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown