BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPONGOSTAN

    MDR report key: 7642867 · Received June 27, 2018

    Report

    Report Number
    3008478369-2018-00004
    Event Type
    Injury
    Date Received
    June 27, 2018
    Product Code
    LMF
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (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 AN UNKNOWN PROCEDURE IN 2016 AND A HEMOSTATIC ABSORBABLE SPONGE WAS USED. THE ANAL SPONGE WAS INSERTED POST OPERATIVELY AND DUE TO SOME FORM OF OVERSIGHT WAS LEFT IN SITU FOR SOME FIFTY HOURS. THIS GAVE RISE TO INFECTION ON TOP OF THE PATIENT'S OTHER PROBLEMS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485717 SPONGOSTAN ABSORBABLE HEMOSTATIC LMF MS0005

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention