BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCL+ UD 36IN 2-0 S/A CT-1

    MDR report key: 11319749 · Received February 11, 2021

    Report

    Report Number
    2210968-2021-01366
    Event Type
    Malfunction
    Date Received
    February 11, 2021
    Date of Event
    January 10, 2021
    Report Date
    January 19, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031056121
    PMA / PMN Number
    K032420
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # : (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH PJ4513 AND NO NON-CONFORMANCES WERE IDENTIFIED. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 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 · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A C-SECTION AND MYOMECTOMY ON (B)(6) 2021 AND THE SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BROKE DURING SEWING. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215746 VCL+ UD 36IN 2-0 S/A CT-1 SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. VCP945H PJ4513 10705031056121

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR