BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HISTOACRYL FLEXIBLE PACK 5

    MDR report key: 8818142 · Received July 23, 2019

    Report

    Report Number
    3003639970-2019-00553
    Event Type
    Injury
    Date Received
    July 23, 2019
    Date of Event
    June 27, 2019
    Report Date
    July 23, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    MPN
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, (B)(4) MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE U.S. K121976. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRODUCT WAS USED FOR AN ENDOSCOPIC SCLEROTHERAPY PROCEDURE OF GASTRIC VARICES. AFTER SURGERY, THE PATIENT DEVELOPED A PULMONARY EMBOLISM. PER THE REPORTER, THE PHYSICIAN WAS NOT AWARE THIS PRODUCT WAS NOT APPLICABLE FOR VASCULAR USE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER, NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611576 HISTOACRYL FLEXIBLE PACK 5 TISSUE ADHESIVES MPN B.BRAUN SURGICAL SA 1051250P 218395N1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other