BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4 FR. S/L POWERPICC - NURSING FULL (TLS)

    MDR report key: 2050937 · Received April 4, 2011

    Report

    Report Number
    3006260740-2011-00097
    Event Type
    Injury
    Date Received
    April 4, 2011
    Date of Event
    October 22, 2010
    Report Date
    March 28, 2011
    Manufacturer
    C. R. BARD, INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K070996
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A CHR REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    PATIENT EXPERIENCED SOB AND CHEST DISCOMFORT AT THE COMPLETION OF PROCEDURE. ELEVATED HEAD, APPLIED 02 AT 2L, AND APPLIED A COOL CLOTH TO HEAD. PATIENT DENIED SOB AND CHEST PAIN WITHIN 5 MIN. PHYSICIAN NOTIFIED OF SUPPORTIVE MEASURES. STILL STATING ANXIOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4 FR. S/L POWERPICC - NURSING FULL (TLS) LJS C. R. BARD, INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention