BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PAINBUSTER: SOAKER 2.5IN: 100ML, 2ML/HR

    MDR report key: 4101658 · Received August 28, 2014

    Report

    Report Number
    2026095-2014-00145
    Event Type
    Injury
    Date Received
    August 28, 2014
    Date of Event
    November 19, 2008
    Report Date
    August 4, 2014
    Manufacturer
    I-FLOW, LLC
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE PRODUCT WAS NOT RETURNED FOR AN EVALUATION AND INVESTIGATION. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE LOT NUMBER REPORTED. RESULTS: THE INFO CONTAINED IS FROM LEGAL DOCUMENTS SERVED ON I-FLOW, LLC. THE COMPLAINT WAS OPENED SO THAT A MED DEVICE REPORT (MDR) CAN BE FILED WITH THE US FOOD AND DRUG ADMINISTRATION. NO FURTHER INVESTIGATION WILL BE CONDUCTED. PER THE DHR REVIEW THERE WERE NO REWORKS, SPECIAL CONDITIONS, OR RELATED NONCONFORMANCE REPORTS (NCRS) FOR THIS LOT. THE LOT MET THE PROCESS SPECIFICATIONS AT RELEASE. CONCLUSIONS: AS THIS COMPLAINT WAS CREATED FROM THE THREAT OF A LAWSUIT RECEIVED BY I-FLOW, LLC; NO CUSTOMER CONTACT CAN BE MADE AT THIS TIME DUE TO THE THREATENED LITIGATION. ON (B)(4) 2007, I-FLOW ALSO PREPARED A TECHNICAL BULLETIN ENTITLED "WHAT WE KNOW ABOUT CHONDROLYSIS TODAY". (1303722, REV. E). INFO FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYS. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    DRUG/DILUENT: MARCAINE 0.5%. FILL VOLUME: UNK - NP. FLOW RATE: UNK - NP. PROCEDURE: RIGHT SHOULDER ARTHROSCOPY SURGERY WITH GLENOHUMERAL DEBRIDEMENT, POSTERIOR BANKART RECONSTRUCTION AND CAPSULORRHAPHY WITH ANTEROINFERIOR CAPSULORRHAPHY. CATHPLACE: SHOULDER JOINT. PT ALLEGES CHONDROLYSIS IN SHOULDER FOLLOWING PLACEMENT OF AN ON-Q PAINBUSTER AFTER SURGERY ON (B)(6) 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526440 ON-Q PAINBUSTER: SOAKER 2.5IN: 100ML, 2ML/HR ELASTOMERIC PUMP MEB I-FLOW, LLC PM012 7A2635

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other GENERAL ANESTHESIA| PROPHYLAXIS ANCEF 1 G, IV