BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICAL SPONGE

    MDR report key: 3759311 · Received April 18, 2014

    Report

    Report Number
    1226348-2014-11391
    Event Type
    Injury
    Date Received
    April 18, 2014
    Product Code
    LWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE RECENTLY REVISED OUR MDR REPORTING PROCEDURES BASED ON FEEDBACK FROM A RECENT FDA AUDIT THAT WAS CONDUCTED IN 2013. ONCE THE CHANGES WERE MADE TO THE PROCEDURES, WE CONDUCTED RETROSPECTIVE REVIEW OF OUR PRODUCT COMPLAINTS AND MDR FILES. THE ATTACHED MDR REPORT IS BEING FILED AS RESULT OF THOSE CHANGES WE MADE TO OUR INTERNAL MDR REPORTING PROCEDURES. PLEASE REFER TO COMPLAINT (B)(4) / MFR# 1226348-2012-00100. A FOLLOW-UP IS BEING GENERATED DUE TO A CHANGE FROM MALFUNCTION TO SERIOUS INJURY. IN ADDITION, A NEW COMPLAINT OF (B)(4) WAS GENERATED AS ADDITIONAL FOLLOW-UP REPORTS COULD NO LONGER BE GENERATED IN THE OLD SYSTEM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THEY HAD AN INCIDENT WHERE THEIR SURGICAL COUNT WAS INCORRECT AND THEY HAD X-RAY TO LOCATE THE PATTY. THE PATTY DID NOT SHOW UP VERY WELL ON X-RAY. IT WAS VERY VERY FAINT. THE RADIOLOGIST TESTED THE PATTIES AT DIFFERENT SETTINGS. THEY DID NOT SHOW UP WELL AT ALL. THE CUSTOMER IS QUITE CONCERNED ABOUT THIS. FURTHER INQUIRIES ARE BEING MADE TO DETERMINE IF COMPLAINT SAMPLES WILL BE MADE AVAILABLE. WE RECENTLY REVISED OUR MDR REPORTING PROCEDURES BASED ON FEEDBACK FROM A RECENT FDA AUDIT THAT WAS CONDUCTED IN 2013. ONCE THE CHANGES WERE MADE TO THE PROCEDURES, WE CONDUCTED RETROSPECTIVE REVIEW OF OUR PRODUCT COMPLAINTS AND MDR FILES. THE ATTACHED MDR REPORT IS BEING FILED AS RESULT OF THOSE CHANGES WE MADE TO OUR INTERNAL MDR REPORTING PROCEDURES. PLEASE REFER TO COMPLAINT (B)(4) / MFR# 1226348-2012-00100. A FOLLOW-UP IS BEING GENERATED DUE TO A CHANGE FROM MALFUNCTION TO SERIOUS INJURY. IN ADDITION, A NEW COMPLAINT OF (B)(4) WAS GENERATED AS ADDITIONAL FOLLOW-UP REPORTS COULD NO LONGER BE GENERATED IN THE OLD SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237712 SURGICAL SPONGE LWH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention