BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAIN PUMP

    MDR report key: 3533855 · Received December 18, 2013

    Report

    Report Number
    2026095-2013-00185
    Event Type
    Injury
    Date Received
    December 18, 2013
    Date of Event
    November 11, 2010
    Report Date
    November 21, 2013
    Manufacturer
    I-FLOW, LLC
    Product Code
    MEB
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: NO PRODUCT WAS RETURNED FOR EVALUATION AND INVESTIGATION. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE THE DEVICE HISTORY RECORDS (DHR) COULD NOT BE REVIEWED. RESULTS: THE INFO CONTAINED IS FROM LEGAL DOCUMENTS SERVED ON I-FLOW, LLC. THE COMPLAINT WAS OPENED SO THAT A MEDICAL DEVICE REPORT (MDR) CAN BE FILED WITH THE US FOOD AND DRUG ADMINISTRATION. NO FURTHER INVESTIGATION WILL BE CONDUCTED. CONCLUSION: AS THIS COMPLAINT WAS CREATED FROM A LAWSUIT SERVED ON I-FLOW, NO CUSTOMER CONTACT CAN BE MADE AT THIS TIME DUE TO THE PENDING LITIGATION. ON 8/8/2007, I-FLOW ALSO PREPARED A TECHNICAL BULLETIN ENTITLED "WHAT WE KNOW ABOUT CHONDROLYSIS TODAY". (1303722, REV. E).

    Description of Event or Problem · 1

    DRUG/DILUENT: UNKNOWN. FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: SHOULDER SURGERY. CATHPLACE: JOINT SPACE. PATIENT ALLEGES CHONDROLYSIS FOLLOWING A PLACEMENT OF A PAIN PUMP ON (B)(6), 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661049 PAIN PUMP ELASTOMERIC PUMP MEB I-FLOW, LLC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other