BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCRYL+ VIO 27IN 0 S/A CT-1

    MDR report key: 15084950 · Received July 22, 2022

    Report

    Report Number
    2210968-2022-05799
    Event Type
    Malfunction
    Date Received
    July 22, 2022
    Date of Event
    June 27, 2022
    Report Date
    July 22, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031046405
    PMA / PMN Number
    K050845
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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, 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. (B)(4). ATTEMPTS HAVE BEEN MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ARE THERE ANY PHOTOS OF THE LABELING ISSUE AVAILABLE? ASSOCIATED EVENTS REPORTED VIA MW# 2210968-2022-05798.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN ANIMAL SURGERY ON (B)(6) 2022 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS TAKEN OUT OF THE BOX AND FOUND TO BE INCORRECT. THE CORRECT PRODUCT WAS SUPPOSED TO BE A DIFFERENT PRODUCT, AND THE BOX DID HAVE PROPER PACKAGING. THE SUTURE IN THE BOX WAS NOT CORRECT. THE PROCEDURE WAS COMPLETED WITH NO HARM. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566117 MCRYL+ VIO 27IN 0 S/A CT-1 SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. MCP340H 10705031046405

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown