BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q-SOAKER 6.5 DUEL SITE PAIN MGM SYSTEM

    MDR report key: 333637 · Received May 14, 2001

    Report

    Report Number
    333637
    Event Type
    Injury
    Date Received
    May 14, 2001
    Date of Event
    March 28, 2001
    Report Date
    May 11, 2001
    Manufacturer
    I-FLOW
    Product Code
    LKK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TWO PROBLEMS WITH ON-Q-SOAKER 6.5 DUEL SITE PAIN MGMT SYSTEM MANUFACTURED BY I-FLOW - SOLD TO RPTR BY ETHICON CO FOR USE IN SURGERY. TWO PTS HAD BUNIONECTOMY PROCEDURES AND BOTH HAD COMPLICATIONS POST SURGERY WITH INFECTIONS. BOTH HAD Q-PUMP IN PLACE POST SURGERY AND BOTH NEEDED EXTENDED CARE (BOTH STILL UNDER MEDICAL FOLLOW-UP). PRODUCT OUT OF SERVICE/USE.

    Description of Event or Problem · 2

    TWO PROBLEMS WITH ON-Q-SOAKER 6.5 DUEL SITE PAIN MANAGEMENT SYSTEM MANUFACTURED BY I-FLOW SOLD TO REPORTER BY ETHICON CO FOR USE IN SURGERY. TWO PTS HAD BUNIONECTOMY-PROCEDURE AND BOTH HAD COMPLICATIONS POST SURGERY WITH INFECTIONS. BOTH HAD Q-PUMP IN PLACE POST SURGERY AND BOTH NEEDED EXTENDED CARE (BOTH STILL UNDER MEDICAL FOLLOW-UP). PRODUCT OUT OF SERVICE/USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22616 ON-Q-SOAKER 6.5 DUEL SITE PAIN MGM SYSTEM CATHETER INSERT FOR PAIN MGM CONTINOUSLY LKK I-FLOW * 0A2825
    22617 ON-Q-SOAKER 6.5 DUEL SITE PAIN MGM SYSTEM CATHETER INSERT FOR PAIN MGM CONTINUOUS LKK I-FLOW * 072598

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other| R 1. CONSULT PHYSICIAN.
    2 53 YR Other| R CONSULT PHYSICIAN.