BEUDAMED
    FDA Adverse Event Other Summary report: N

    OHIO MEDICAL

    MDR report key: 3182070 · Received June 17, 2013

    Report

    Report Number
    1419185-2013-00002
    Event Type
    Other
    Date Received
    June 17, 2013
    Report Date
    June 14, 2013
    Manufacturer
    OHIO MEDICAL CORP
    Product Code
    KDP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN SENT TO OHIO MEDICAL CORP. OHIO MEDICAL CORP ENGINEERING AND QUALITY PERSONNEL HAVE SPOKEN TO (B)(6). SINCE (B)(6) WAS INFORMED OF THE INCIDENT BY A DIFFERENT PERSON, HE WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    (B)(6) HOSPITAL, (B)(6), CALLED OHIO MEDICAL CORP; (B)(6) IS THE BIOMEDICAL TECHNICIAN THAT REPORTED THE INCIDENT. (B)(6) REPORTED THAT ONE OF OUR PUSH-TO-SET VACUUM REGULATOR WAS RECENTLY INVOLVED IN A PT INJURY; HOWEVER HE DID NOT HAVE ANY OTHER SPECIFIC INFORMATION REGARDING THE SERIAL NUMBER OR THE INVOLVEMENT OF THE UNIT FOR THIS PARTICULAR INCIDENT AT THE TIME AS HE HAS NOT BEEN INFORMED OF ANY ADDITIONAL INFORMATION IN REGARD TO THIS UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274483 OHIO MEDICAL SUCTION REGULATOR KDP OHIO MEDICAL CORP PTS ISU NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other