BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

    MDR report key: 7065507 · Received November 28, 2017

    Report

    Report Number
    2210968-2017-71472
    Event Type
    Injury
    Date Received
    November 28, 2017
    Report Date
    November 6, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    LMF
    PMA / PMN Number
    N12159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. CITATION: ORAL SURG ORAL MED ORAL PATHOL ORAL RADIOL ENDOD 2001;92:257-259. DOI:10.1067/MOE.2001.115463

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE (COMPARISON OF 2 HEMOSTATIC AGENTS FOR THE PREVENTION OF POSTEXTRACTION HEMORRHAGE IN PATIENTS ON ANTICOAGULANTS) THAT THE PATIENT UNDERWENT A TOOTH EXTRACTION PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. THE PATIENT EXPERIENCED POST-OPERATIVE HEMORRHAGE, THAT REQUIRED FURTHER SUTURING. THE PATIENT POSSIBLE EXPERIENCED PAIN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844372 SURGICEL ABSORBABLE HEMOSTAT UNKNOWN HEMOSTATIC AGENT, ABSORBABLE LMF ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1