BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q SILVERSOAKER CATHETER

    MDR report key: 1943705 · Received December 15, 2010

    Report

    Report Number
    2026095-2010-00309
    Event Type
    Other
    Date Received
    December 15, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 17, 2010
    Manufacturer
    I-FLOW CORP.
    Product Code
    BSO
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    PT REPORTED A METALLIC TASTE AND CARDIAC PROBLEMS FOLLOWING THE USE OF THE PAIN PUMP ON (B)(6) 2010. SHE WAS TREATED IN THE ER. SHE THEN HAD A PSYCHOLOGICAL BREAKDOWN AND IS BEING TREATED WITH PSYCHOLOGICAL MEDICATIONS. THE PHYSICIAN STATED THAT THE PUMP DID NOT MALFUNCTION, FINISHING IN THE EXPECTED TIMEFRAME, AND DID NOT FEEL THE PT SUFFERED FROM DRUG EFFECTS AS THE SYMPTOMS EXPERIENCED WERE ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q SILVERSOAKER CATHETER CATHETER BSO I-FLOW CORP. PM025-A ANP

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other