BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-COMP SWVLK SP, 4.75X24.5MM

    MDR report key: 19587945 · Received June 21, 2024

    Report

    Report Number
    1220246-2024-06346
    Event Type
    Injury
    Date Received
    June 21, 2024
    Date of Event
    May 10, 2019
    Report Date
    August 29, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    UDI-DI
    00888867026865
    PMA / PMN Number
    K191226
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER AN INITIAL ROTATOR CUFF SUTURE SURGERY ON (B)(6) 2019 THE PATIENT STARTED TO EXPERIENCED MAJOR PROBLEMS (REDNESS, ITCHING AND PARTIALLY OPEN AREAS) AT THE OPERATED SITE. NO FURTHER INFORMATION RECEIVED. UPDATE DW 29-MAY-2024: THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2019 IN (B)(6) AND AN MEDICAL EXAMINATION WILL BE PERFORMED ON (B)(6) 2024 IN (B)(6).

    Description of Event or Problem · 0

    UPDATE DW (B)(6) 2024: THE CUSTOMER PROVIDED FURTHER INFORMATION THAT THERE IS NO CONNECTION BETWEEN THE REPORTED EVENT AND THE ARTHREX PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201085 BIO-COMP SWVLK SP, 4.75X24.5MM BIO SOFT TISSUE FIXATN FASTNR MAI ARTHREX, INC. BIO-COMP SWVLK SP, 4.75X24.5MM 10264484 00888867026865

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other