BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLOG ZAPPER

    MDR report key: 294282 · Received August 29, 2000

    Report

    Report Number
    1419949-2000-00012
    Event Type
    Other
    Date Received
    August 29, 2000
    Date of Event
    May 5, 2000
    Report Date
    August 17, 2000
    Manufacturer
    CORPAK MEDSYSTEMS
    Product Code
    FPD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    CLOG ZAPPER BEING USED TO UNBLOCK PT'S JEJUNOSTOMY TUBE, "WHEN BACK PRESSURE FORCED A SPRAY OF ENZYME INTO THE EYE" OF AN OBSERVER. HOSP REPORTS ON 08/02/2000 THAT THE OBSERVER, "CONTINUES TO BE IN THE CARE OF THE OPHTHALMIC DEPT AND IS UNABLE TO WEAR CONTACT LENSES, WHICH OBSERVER HAS PREVIOUSLY WORN FOR MANY YEARS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLOG ZAPPER ENTERAL FEEDING TUBE DECLOGGING SYSTEM FPD CORPAK MEDSYSTEMS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other