BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPRAMID BLACK 5/0 (1) 45CM DS16

    MDR report key: 8259079 · Received January 17, 2019

    Report

    Report Number
    3003639970-2019-00054
    Event Type
    Malfunction
    Date Received
    January 17, 2019
    Report Date
    January 18, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAR
    PMA / PMN Number
    K990090
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER, REGISTRATION NO. 3003639970). EXEMPTION NUMBER: E2014012 MANUFACTURING SITE EVALUATION: INVESTIGATION ONGOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO. (B)(4)) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER, REGISTRATION NO. (B)(4)). EXEMPTION NUMBER: E2014012. PMA/510K: K990090. REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE U.S.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BOX CONTAINING SUTURE PACKAGES WAS RECEIVED INCORRECTLY LABELED. PRIOR TO USE, IT WAS NOTED THAT THERE HAD BEEN A MIX-UP WITH THE PRINTING ON A BOX. THE CUSTOMER HAD ORDERED SUPRAMID SUTURES AND THE BOX HAD MONOSYN LABELING. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49125 SUPRAMID BLACK 5/0 (1) 45CM DS16 OTHER SUTURE GAR B.BRAUN SURGICAL SA G0712124 618386

    Patients

    Seq Age Sex Outcome Treatment
    1