BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HISTOACRYL TISSUE ADHES.TRNS 0.5ML

    MDR report key: 5454498 · Received February 23, 2016

    Report

    Report Number
    2916714-2016-00107
    Event Type
    Malfunction
    Date Received
    February 23, 2016
    Date of Event
    February 3, 2016
    Report Date
    February 23, 2016
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    MPN
    PMA / PMN Number
    NARRATIVE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012. MANUFACTURING SITE EVALUATION: AN EVALUATION WAS NOT PERFORMED. PRODUCT EXPIRED AT TIME OF COMPLAINT. NO FURTHER ACTION REQUIRED. PRODUCT EXPIRED.

    Additional Manufacturer Narrative · 1

    REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR ANY OTHER TECHNOLOGICAL CHARACTERISTICS WITH A MEDICAL DEVICE REGISTERED WITHIN THE U.S. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). THE CUSTOMER USE 1050060 AFTER DILUTING WITH LIPIODOL HISTOACRYL. RELATING TO RECENTLY MANUFACTURED PRODUCT, HE TOLD US THAT THE ADHESIVE STRENGTH WAS WEAKENED COMPARED TO USUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109906 HISTOACRYL TISSUE ADHES.TRNS 0.5ML TISSUE ADHESIVES MPN B.BRAUN SURGICAL SA 1050060 212381N2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other