BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TULA TDS 1.14 GROMMET

    MDR report key: 12957378 · Received December 7, 2021

    Report

    Report Number
    3012130335-2021-00002
    Event Type
    Injury
    Date Received
    December 7, 2021
    Date of Event
    November 16, 2021
    Report Date
    May 31, 2022
    Manufacturer
    TUSKER MEDICAL INC.
    Product Code
    QJA
    UDI-DI
    00840128600078
    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

    INTERNAL COMPLAINT REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    H2: CORRECTION IN D4 (UDI NO).

    Additional Manufacturer Narrative · 0

    H10: C, SUSPECTED PRODUCTS, ITEM 1: UPDATED. C3: TULA IONTOPHORESIS SYSTEM PROVIDES AN ELECTRICAL DOSE OF 6.36MAMIN TO DRIVE IONS OF LIDOCAINE AND EPINEPHRINE INTO THE TYMPANIC MEMBRANE IN A ~10-12 MINUTE APPLICATION.

    Additional Manufacturer Narrative · 0

    H3, H6: THE REPORTED DEVICE WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION, THUS VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTED EVENTS. THE INSTRUCTIONS FOR USE WAS REVIEWED AND FOUND INSTRUCTIONS TO ENSURE THE PATIENT'S HEAD IS STABILIZED AND THE CLEAR TIP IS FULLY APPOSED AGAINST THE TM. A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE WAS DOCUMENTED APPROPRIATELY. CLINICAL EVALUATION FOUND THAT, BASED ON THE LIMITED INFORMATION PROVIDED, WE ARE CURRENTLY UNABLE TO RULE OUT A PROCEDURAL VARIANCE AS A CONTRIBUTING FACTOR TO THE REPORTED EVENT, WHICH DOES NOT REPRESENT A DEVICE MALFUNCTION. SINCE NO PATIENT INJURIES ARE BEING REPORTED NO FURTHER CLINICAL/MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. IT WAS DETERMINED THE DEVICE CONTRIBUTED TO THE REPORTED EVENT. THE COMPLAINT WAS CONFIRMED AND THE ROOT CAUSE WAS ASSOCIATED WITH A FAILURE TO FOLLOW INSTRUCTIONS. THE INSTRUCTIONS FOR USE WARNS OF COMPLICATIONS IF THE PATIENT'S HEAD IS NOT STABILIZED, AND THE COMPLAINT DESCRIPTION STATES THAT IT WAS NOT POSSIBLE GET THE PATIENT "TO HOLD STILL LONG ENOUGH TO GET PROPER APPOSITION TO THE TM." 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A TYMPANOSTOMY, THE TULA EARPLUG SIZE 1 HAS TO BE REPLACED BECAUSE THERE WAS A LEAK. THE PATIENT WOULDN'T SIT STILL, THE PHYSICIAN HAD 2 SHORT SHOTS ON THE RIGHT EAR AND 1 ON THE LEFT EAR. AFTER THE SHORT SHOT ON THE LEFT SIDE, THE DOCTOR SCHEDULED THE PATIENT FOR THE OR. THERE WAS NO PATIENT INJURIES BUT THE PROCEDURE WAS NOT SUCCESSFUL AS IT WAS NOT POSSIBLE TO HOLD THE PATIENT STILL LONG ENOUGH TO GET PROPER APPOSITION TO THE TM. THE PATIENT CURRENT STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1855668 TULA TDS 1.14 GROMMET TYMPANOSTOMY TUBE DELIVERY PRODUCT WITH DRUG QJA TUSKER MEDICAL INC. 21031701 00840128600078

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention