BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICRYL CT VIO 90CM M4

    MDR report key: 11306962 · Received February 10, 2021

    Report

    Report Number
    2210968-2021-01246
    Event Type
    Malfunction
    Date Received
    February 10, 2021
    Date of Event
    January 1, 2021
    Report Date
    January 12, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). DATE SENT TO THE FDA: 04/12/2021. ADDITIONAL INFORMATION: H6, H4. D4. H6 COMPONENT CODE: G07002 - NO DEVICE PROBLEM FOUND. 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS ARE BEING MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. NOTE: EVENTS REPORTED VIA MW# 2210968-2021-01243, 2210968-2021-01244, 2210968-2021-01245. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ANIMAL UNDERWENT SURGICAL PROCEDURE FOR DEHISCENCE ON (B)(6) 2021 AND SUTURE USED ON THE OVERJET OF THE ABDOMINAL WALL. ON (B)(6) 2021, THE SUTURE BROKE ON THE LENGTH OF THE WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202811 VICRYL CT VIO 90CM M4 SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. QDBDLZR0

    Patients

    Seq Age Sex Outcome Treatment
    1