BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q C-BLOC WITH SAF PUMP

    MDR report key: 1943704 · Received December 15, 2010

    Report

    Report Number
    2026095-2010-00307
    Event Type
    Other
    Date Received
    December 15, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 16, 2010
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE HAS NOT YET BEEN RECEIVED, BUT WAS REPORTED TO BE AVAILABLE. THE SAMPLE WILL BE EVALUATED WHEN RECEIVED AND A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT EXPERIENCED RINGING IN THE EARS AND VISUAL DISTURBANCES DURING THE USE OF A PAIN PUMP. PUMP WAS PLACED ON (B)(6) 2010. AT PHYSICAL THERAPY ON (B)(6) 2010, ALL WAS WELL. AT ABOUT 2:30 AM (B)(6) 2010, SHE CONTACTED THE FELLOW AT THE FACILITY. AT PHYSICAL THERAPY ON (B)(6) 2010, THE CATHETER WAS REMOVED, AND THE PUMP WAS EMPTY. IT IS UNK IF PUMP WAS CLAMPED DURING THE 2:30 AM CALL, BUT THE CLAMP WAS OPENED UPON EXAMINATION BY SALES REP ON (B)(6) 2010. PT IS NOW STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q C-BLOC WITH SAF PUMP ELASTOMERIC PUMP MEB I-FLOW CORP. CB004 082236

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other