BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TULA CONTROL UNIT SPARE

    MDR report key: 18512357 · Received January 15, 2024

    Report

    Report Number
    3012130335-2024-00001
    Event Type
    Injury
    Date Received
    January 15, 2024
    Date of Event
    December 18, 2023
    Report Date
    March 12, 2024
    Manufacturer
    TUSKER MEDICAL INC.
    Product Code
    QJA
    UDI-DI
    00840128600146
    PMA / PMN Number
    P190016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: H3, H6: A DEVICE DEFICIENCY WAS NOT IDENTIFIED, AND THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED AND THUS A MANUFACTURING RECORD REVIEW COULD NOT BE CONDUCTED. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND NO SIMILAR REPORTED EVENTS. THE INSTRUCTIONS FOR USE WAS REVIEWED AND FOUND TO INCLUDE CONDITIONS OF OFF LABEL USE AND TECHNIQUE SPECIFICS, AS WELL AS PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE AND/OR HARM WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR RECOMMENDATIONS ON PROPER USE OF THE DEVICE AND POTENTIAL TROUBLESHOOTING METHODS TO PREVENT FUTURE REOCCURRENCE OF THE REPORTED EVENT. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED AT A FUTURE DATE, THIS INVESTIGATION WILL BE REOPENED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN IN-OFFICE BILATERAL TULA PROCEDURE, THE SURGEON FACED DIFFICULTY TO FIND A PROPER SEAL ATTEMPTING TO USE TWO (2) EARPLUGS SIZE 2, 3 AND ONE (1) EARPLUG SIZE 4. IONTOPHORESIS WAS COMPLETED SUCCESSFULLY WITH NO ALARMS; HOWEVER DURING THIS STAGE OF THE PROCEDURE THE PATIENT COMPLAINED ABOUT DISCOMFORT AND PAIN; WHICH LEAD TO USE REDUCE MODE. LATER ON THE SURGEON DEPLOYED SUCCESSFULLY THE TDS ON THE LEFT EAR; HOWEVER THE PATIENT COMPLAINED OF DISCOMFORT AND PAIN ON THE RIGHT EAR. THE PROCEDURE WAS RESCHEDULED FOR THE OR. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731459 TULA CONTROL UNIT SPARE TYMPANOSTOMY TUBE DELIVERY PRODUCT WITH DRUG QJA TUSKER MEDICAL INC. UNKNOWN 00840128600146

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Male Other EP2B| EP3G| EP4Y