BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUA SEAL CDU

    MDR report key: 167508 · Received May 15, 1998

    Report

    Report Number
    9611018-1998-00004
    Event Type
    Injury
    Date Received
    May 15, 1998
    Report Date
    April 15, 1998
    Manufacturer
    SHERWOOD MEDICAL INDUSTRIES
    Product Code
    KDQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE MFR COMPLAINT # 98042201TL. NO SAMPLES WERE RETURNED AND NO RESPONSE WAS GIVEN TO CO'S QUESTIONNAIRE. A LOT HISTORY CHECK WAS PERFORMED AND WAS UNREMARKABLE. INFORMATION ON AIR LEAKS (SOURCE AND MEANING) WAS PROVIDED FOR THE COMPLAINANT. MANUFACTURING PERSONNEL HAVE BEEN INFORMED OF THIS COMPLAINT. NO OTHER ACTION POSSIBLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTS "AIR POCKETS" FORMED ON THE PT WHEN THE AQUA-SEAL WAS USED. (POSSIBLE PNEUMOTHORAX?). CUSTOMER CLAIMS THAT BECAUSE THE AMOUNT OF BUBBLING CAN BE CHANGED SO EASILY, THE AQUA SEAL WILL NOT MAINTAIN THE CORRECT AMOUNT OF SUCTION. THE DOCTOR CHANGED FROM THE AQUA SEAL TO THE PLEUREVAC A6000 AND CLAIMED THAT IT WORKED FINE. NO ADDITIONAL DETAILS WERE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUA SEAL CDU CHEST DRAINAGE UNIT KDQ SHERWOOD MEDICAL INDUSTRIES NA 97K259T

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other