BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VCL+ UD 36IN 1 S/A CTX

    MDR report key: 9323895 · Received November 14, 2019

    Report

    Report Number
    2210968-2019-89927
    Event Type
    Injury
    Date Received
    November 14, 2019
    Date of Event
    September 14, 2019
    Report Date
    October 24, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031056251
    PMA / PMN Number
    K032420
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #:(B)(4). (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 PDZ980 BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THIS MEDWATCH REPORT IS IN RESPONSE TO RECEIPT OF MAUDE EVENT REPORT MW 5090083.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE NEEDLE TIP BROKE OFF DURING THE PROCEDURE. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. THE PATIENT UNDERWENT AN UNKNOWN SURGICAL INTERVENTION. NO ADDITIONAL INFORMATION CAN BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1115147 VCL+ UD 36IN 1 S/A CTX SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. PDZ980 10705031056251

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention