BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TYMBION AND SYRINGE PACK

    MDR report key: 18512422 · Received January 15, 2024

    Report

    Report Number
    3012130335-2024-00002
    Event Type
    Injury
    Date Received
    January 15, 2024
    Date of Event
    December 18, 2023
    Report Date
    May 2, 2024
    Manufacturer
    TUSKER MEDICAL INC.
    Product Code
    QJA
    UDI-DI
    00840128600139
    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

    H3, H6: A DEVICE DEFICIENCY WAS NOT IDENTIFIED, AND THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED BASED ON THE PROVIDED EVIDENCE. LOT INFORMATION WAS NOT AVAILABLE THEREFORE A REVIEW OF THE LOT HISTORY RECORDS COULD NOT BE PERFORMED. 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 TULA PROCEDURE, SURGEON FACED DIFFICULTY TO FIND A SIZE FOR AN ATYPICALLY SMALL EAR; SURGEON ATTEMPTED TO USE SIZES 4, 3, 2 AND 1 OF EARPLUGS IN ORDER TO FIND A PROPER SEAL DURING THE FILL. IONTOPHORESIS WAS COMPLETED SUCCESSFULLY WITHOUT ALARMS NOR INTERRUPTIONS; HOWEVER WHEN THE SURGEON TESTED THE TYMPANIC MEMBRANE TO DETERMINE IF IT WAS PROPERLY ANESTHETIZED UTILIZING THE TDS DEVICE, THE PATIENT COMPLAINED OF DISCOMFORT. THE PROCEDURE WAS ULTIMATELY ABORTED AND THE PATIENT RESCHEDULED FOR THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1114671 TYMBION AND SYRINGE PACK TYMPANOSTOMY TUBE DELIVERY PRODUCT WITH DRUG QJA TUSKER MEDICAL INC. UNKNOWN 00840128600139

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other| R EP1P.| EP2B.| EP3G.| EP4Y.