BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60MM REINFORCEMENT

    MDR report key: 14278164 · Received May 4, 2022

    Report

    Report Number
    3005075853-2022-02820
    Event Type
    Malfunction
    Date Received
    May 4, 2022
    Date of Event
    April 12, 2022
    Report Date
    May 3, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    OXC
    UDI-DI
    10705036023296
    PMA / PMN Number
    K190937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). BATCH #: UNK. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO [NON-CONFORMANCES/ MANUFACTURING IRREGULARITIES] WERE IDENTIFIED. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 6/2/2022 . ADDITIONAL INFORMATION: AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICES WERE FOUND ON THEIR SHELVES WITH THE INDICATORS BEING PINK. FACILITY STATED THAT THEY HAVE BEEN USING THESE SINCE THE FOURTH OF APRIL AND ARE UNSURE IF ANY OF THE LABELS OF THE DEVICES USED WERE ALSO PINK. NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1442828 ECHELON 60MM REINFORCEMENT OXC OXC ETHICON ENDO-SURGERY, LLC. ECH60R RBCCMSS0 10705036023296

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown