BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIFLO

    MDR report key: 7643050 · Received June 27, 2018

    Report

    Report Number
    3008478369-2018-00002
    Event Type
    Injury
    Date Received
    June 27, 2018
    Date of Event
    May 20, 2014
    Product Code
    LMF
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # ==> PC-(B)(4). DATE SENT TO THE FDA: 09/23/2020. CORRECTED INFORMATION: B1, B2, H1 ¿ THIS MEDWATCH IS NOT REPORTABLE BY ETHICON, INC. AS THE IMPORTER BECAUSE THIS DEVICE WAS NOT IMPORTED INTO THE USA. THEREFORE, THIS MEDWATCH REPORT IS BEING VOIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE ON AN UNKNOWN DATE AND AN ABSORBABLE HEMOSTAT WAS USED. FOLLOWING THE PROCEDURE, THE DEVICE BECAME HARD (DID NOT ABSORB)AND FORMED A CAPSULE. FOR THAT REASON, A REVISION SURGERY BECAME NECESSARY AND THE ENCAPSULATED PRODUCT WAS REMOVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485732 SURGIFLO ABSORBABLE HEMOSTATIC AGENT LMF MS0011 242813

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R