BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SFX SPI PDS+ UNI VIO 12IN 0 S/A CT-1

    MDR report key: 13407745 · Received February 1, 2022

    Report

    Report Number
    2210968-2022-00761
    Event Type
    Malfunction
    Date Received
    February 1, 2022
    Date of Event
    January 6, 2022
    Report Date
    January 31, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    UDI-DI
    10705031236219
    PMA / PMN Number
    K182873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. TRADE NAME - IRGACARE®, ACTIVE INGREDIENT(S) ¿ TRICLOSAN, DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL, STRENGTH ¿ 2360 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 TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE ON (B)(6) 2022 AND BARBED SUTURE WAS USED. THE SUTURE BROKE AT THE 2ND BACKSTITCH ON THE VAGINAL STUMP DURING CONTINUOUS SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1085058 SFX SPI PDS+ UNI VIO 12IN 0 S/A CT-1 SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE NEW ETHICON INC. SXPP1B450 RHBAPX 10705031236219

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown