BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SFX SYM PDS+ UNI VIO 18IN 1 S/A CT

    MDR report key: 14415335 · Received May 17, 2022

    Report

    Report Number
    2210968-2022-03764
    Event Type
    Malfunction
    Date Received
    May 17, 2022
    Date of Event
    January 1, 2022
    Report Date
    May 16, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    UDI-DI
    10705031227682
    PMA / PMN Number
    K113004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). COMPONENT CODE: (B)(4) DEVICE NOT RETURNED. 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-CONFORMANCE'S 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: 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

    HOLD BJ 5.17.22

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1836383 SFX SYM PDS+ UNI VIO 18IN 1 S/A CT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. SXPP1A405 RLMPRK 10705031227682

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown