BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TULA KIT - BILATERAL

    MDR report key: 19499068 · Received June 10, 2024

    Report

    Report Number
    3012130335-2024-00003
    Event Type
    Injury
    Date Received
    June 10, 2024
    Date of Event
    May 16, 2024
    Report Date
    August 7, 2024
    Manufacturer
    TUSKER MEDICAL INC.
    Product Code
    QJA
    UDI-DI
    00840128600023
    PMA / PMN Number
    P190016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    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 AND A STERILIZATION 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. A CLINICAL REVIEW STATES THE PROCEDURE WAS CANCELED AND SCHEDULED FOR THE OR DUE TO THE PATIENT BEHAVIOR. THE IMPACT TO THE PATIENT WAS THE REPORTED DISCOMFORT, THE ABORTED PROCEDURE, AND THE ASSOCIATED RISK BY ADDING AN OPERATING ROOM PROCEDURE. SINCE NO PATIENT HARM OR OTHER COMPLICATIONS WERE REPORTED, NO FURTHER CLINICAL/MEDICAL ASSESSMENT CAN BE RENDERED AT THIS TIME. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED AT A FUTURE DATE, THIS INVESTIGATION WILL BE REOPENED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    H11: H2: CORRECTED DATA ON: B1 & B2.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A BILATERAL TYMPANOSTOMY, WHILE USING THE TULA KIT, THE PATIENT WAS HAVING A HARD TIME WITH IONTOPHORESIS, THE DOCTOR AND THE PARENTS TRIED TO CALM THE PATIENT WITHOUT SUCCESS, THUS, THE PROCEDURE WAS CANCELED AND SCHEDULED FOR THE OPERATING ROOM DUE TO BEHAVIORAL ISSUES. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149677 TULA KIT - BILATERAL TYMPANOSTOMY TUBE DELIVERY PRODUCT WITH DRUG QJA TUSKER MEDICAL INC. UNKNOWN 00840128600023

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Male Other