BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STFX SYM PDS+ UNI VIO 24IN 1 S/A CTX

    MDR report key: 14074813 · Received April 11, 2022

    Report

    Report Number
    2210968-2022-02567
    Event Type
    Malfunction
    Date Received
    April 11, 2022
    Date of Event
    March 15, 2022
    Report Date
    April 11, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    UDI-DI
    10705031245273
    PMA / PMN Number
    K141776
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WAS THE NEEDLE PIECE REMOVED FROM THE PATIENT? LOT NUMBER? PATIENT CONDITION? 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2022 AND BARBED SUTURE WAS USED. THE NEEDLE POPPED OFF OF A SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2444058 STFX SYM PDS+ UNI VIO 24IN 1 S/A CTX SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE NEW ETHICON INC. SXPP1A445 10705031245273

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown