BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDS PLUS VIO 96IN 1 S/A XLH LP

    MDR report key: 17927296 · Received October 12, 2023

    Report

    Report Number
    2210968-2023-07706
    Event Type
    Malfunction
    Date Received
    October 12, 2023
    Date of Event
    September 19, 2023
    Report Date
    October 12, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    UDI-DI
    10705031048676
    PMA / PMN Number
    K061037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # :(B)(4). H6. COMPONENT CODE: G07002 - 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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: - DID THE NEEDLE FALL INTO THE PATIENT? NO, THE NEEDLE DID NOT FALL INTO THE PATIENT. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. EVENT RELATED TO MW # 2210968-2023-07707. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, PART 4 SUBPART B. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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 GYN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE THEY WERE GOING THROUGH TOUGH SKIN AND A COUPLE OF THE NEEDLES BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2115686 PDS PLUS VIO 96IN 1 S/A XLH LP SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. SJMAQK 10705031048676

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown