BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SFX SPI PDS+ UNI 12IN 4-0 SA PS-2 PRM MP

    MDR report key: 14162235 · Received April 20, 2022

    Report

    Report Number
    2210968-2022-02799
    Event Type
    Malfunction
    Date Received
    April 20, 2022
    Report Date
    April 20, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    UDI-DI
    10705031235984
    PMA / PMN Number
    K150670
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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: PLEASE PROVIDE THE LOT NUMBER:=>NO FURTHER INFORMATION IS AVAILABLE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. TRADE NAME: (B)(4), 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 AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON TRIED TO SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272694 SFX SPI PDS+ UNI 12IN 4-0 SA PS-2 PRM MP SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE NEW ETHICON INC. SXPP1B112 10705031235984

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown