BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCL+ VIO 27IN 3-0 S/A SH-1

    MDR report key: 14269371 · Received May 3, 2022

    Report

    Report Number
    2210968-2022-03201
    Event Type
    Malfunction
    Date Received
    May 3, 2022
    Date of Event
    March 22, 2022
    Report Date
    May 2, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031052192
    PMA / PMN Number
    K132580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. TRADE NAME - IRGACARE®, ACTIVE INGREDIENT(S) ¿ TRICLOSAN, DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL, STRENGTH ¿ = 275 G/M. 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 · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A WOUND CLOSURE PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE NEEDLE PULLED OFF OF THE SUTURE WITH A NEWLY DISPENSED SUTURE. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED AGAIN WHEN SEWING THE INCISION DURING THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1500872 VCL+ VIO 27IN 3-0 S/A SH-1 SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. VCP311H QMBCZCW0 10705031052192

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female