BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUN-L-XL/24

    MDR report key: 7615729 · Received June 19, 2018

    Report

    Report Number
    1316297-2018-00004
    Event Type
    Malfunction
    Date Received
    June 19, 2018
    Date of Event
    September 7, 2017
    Report Date
    June 19, 2018
    Manufacturer
    EPIMED INTERNATIONAL INC
    Product Code
    BSO
    UDI-DI
    00818788021212
    PMA / PMN Number
    K954584
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER MDR REPORT MW5077449, SUBMITTED BY (B)(6) TO THE FDA ON MAY 24, 2018: PT HAD CATHETER PLACED FOR LOA PROCEDURE (B)(6) 2017. PT LEFT (B)(6) WITH CATHETER SECURED FOR INFUSION AT (B)(6) CLINIC NEXT DAY (B)(6) 2017. CATHETER REMOVED (B)(6) 2017 IN OFFICE. PER MD PT C/O BACK ISSUES SINCE REMOVAL. FB IDENTIFIED. DATES OF USE; (B)(6) 2017 - (B)(6) 2017. DIAGNOSIS OR REASON FOR USE: LOW BACK AND LEFT LEG PAIN. M. DEVICES GROUP, (B)(6). EPIMED RECEIVED A LETTER FROM THE DEPARTMENT OF HEALTH AND HUMAN SERVICES DATED MAY 30, 2018. THE LETTER WAS TO NOTIFY EPIMED OF AN MDR THAT WAS FILED BY (B)(6) REGARDING A PATIENT EVENT WHERE THE CATHETER HAD BEEN REMOVED BY THE FACILITY BUT THE PATIENT WAS REPORTEDLY STILL EXPERIENCING BACK PAIN. THE VOLUNTARY EVENT REPORT (MW5077449) STATED THAT THE FACILITY HAD LOCATED A FOREIGN BODY WITHIN THE PATIENT. NO ADDITIONAL INFORMATION WAS REPORTED TO EPIMED REGARDING THE USER NAME, REPORTER NAME, SPECIFIC FACILITY LOCATION, CONTACT INFORMATION OR ACTIONS TO BE TAKEN BY THE REPORTING FACILITY IN RESPONSE TO THE FOREIGN BODY THAT WAS IDENTIFIED.

    Description of Event or Problem · 1

    PER MDR REPORT MW5077449, SUBMITTED BY (B)(6) TO THE FDA ON MAY 24, 2018: PT HAD CATHETER PLACED FOR LOA PROCEDURE (B)(6) 2017. PT LEFT (B)(6) WITH CATHETER SECURED FOR INFUSION AT (B)(6) CLINIC NEXT DAY (B)(6) 2017. CATHETER REMOVED (B)(6) 2017 IN OFFICE. PER MD PT C/O BACK ISSUES SINCE REMOVAL. FB IDENTIFIED. DATES OF USE; (B)(6) 2017 - (B)(6) 2017. DIAGNOSIS OR REASON FOR USE: LOW BACK AND LEFT LEG PAIN. M. DEVICES GROUP, (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460087 TUN-L-XL/24 CATHETER BSO EPIMED INTERNATIONAL INC A-EP-089 11427899 00818788021212

    Patients

    Seq Age Sex Outcome Treatment
    1 Other