BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 20301458 · Received September 25, 2024

    Report

    Report Number
    3012130335-2024-00007
    Event Type
    Injury
    Date Received
    September 25, 2024
    Date of Event
    September 5, 2024
    Report Date
    September 25, 2024
    Manufacturer
    TUSKER MEDICAL INC.
    Product Code
    QJA
    UDI-DI
    00885556817742
    PMA / PMN Number
    P190016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE NUMBER: (B)(4). H3, H6: THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PATIENT COMPLICATION REPORTED THAT INCLUDES REFERENCE TO THE USE OF A SMITH+NEPHEW PRODUCT WITHOUT EVIDENCE ABOUT A SPECIFIC PRODUCT PROBLEM. THE REPORTED COMPLICATION RELATES TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED. SMITH+NEPHEW HAS NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON OUR REVIEW OF ALL CURRENTLY AVAILABLE INFORMATION, WE ARE UNABLE TO CONFIRM A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE OR IDENTIFY A DEFINITIVE ROOT CAUSE. HOWEVER, AS THE USE OF OUR PRODUCT CANNOT BE EXCLUDED AS A POTENTIAL CAUSE OR CONTRIBUTORY FACTOR TO THE REPORTED ISSUE, WE ARE CONSERVATIVELY SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED. D4, LOT NO.: THE FOLLOWING ARE THE PART NUMBERS & LOT NUMBERS OF THE TWO DEVICES REPORTED: PART NUMBER: 72290103/LOT NUMBER: TUG17241, PART NUMBER: 72290097/LOT NUMBER: UNKNOWN. D4, EXP. DATE: EXPIRATION DATES FOR EACH OF THE 2 LOT NUMBERS REPORTED: 18-OCT-2025 (PART NUMBER: 72290103/LOT NUMBER: TUG17241) & UNKNOWN (PART NUMBER: 72290097/LOT NUMBER: UNKNOWN). D4, UNIQUE IDENTIFIER (UDI) #: UNIQUE IDENTIFIER NUMBER FOR EACH OF THE TWO DEVICES REPORTED: (B)(4) (PART NUMBER: 72290103) & (B)(4) (PART NUMBER: 72290097). H4, MGF. DATE: MANUFACTURING DATES FOR EACH OF THE 2 LOT NUMBERS REPORTED: 24-APR-2024 (PART NUMBER: 72290103/LOT NUMBER: TUG17241) & UNKNOWN (PART NUMBER: 72290097/LOT NUMBER: UNKNOWN). D1: BRAND NAME WAS CHANGED TO UNKNOWN DUE TO THE TWO DEVICES REPORTED: (72290103) TULA CONTROL UNIT SPARE (NST007065) & (72290097) TULA TDS 1.14 GROMMET (STR007011).

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE NUMBER: (B)(4). H3, H6: THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PATIENT COMPLICATION RELATED TO A PRODUCT PROBLEM WITH A SMITH+NEPHEW DEVICE. THE REPORTED ISSUE(S) RELATE TO KNOWN INHERENT DEVICE AND/OR PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED. SMITH+NEPHEW HAS NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON OUR REVIEW OF ALL CURRENTLY AVAILABLE INFORMATION, WE ARE UNABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE. HOWEVER, AS THE USE OF OUR PRODUCT CANNOT BE EXCLUDED AS A POTENTIAL CAUSE OR CONTRIBUTORY FACTOR TO THE REPORTED ISSUE, WE ARE CONSERVATIVELY SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED. D4, LOT NO.: THE FOLLOWING ARE THE PART NUMBERS & LOT NUMBERS OF THE TWO DEVICES REPORTED: PART NUMBER: 72290103/LOT NUMBER: TUG17241, PART NUMBER: 72290097/LOT NUMBER: UNKNOWN. D4, EXP. DATE: EXPIRATION DATES FOR EACH OF THE 2 LOT NUMBERS REPORTED: 18-OCT-2025 (PART NUMBER: 72290103/LOT NUMBER: TUG17241) & UNKNOWN (PART NUMBER: 72290097/LOT NUMBER: UNKNOWN). D4, UNIQUE IDENTIFIER (UDI) #: UNIQUE IDENTIFIER NUMBER FOR EACH OF THE TWO DEVICES REPORTED: (B)(4) (PART NUMBER: 72290103) & (B)(4) (PART NUMBER: 72290097). H4, MGF. DATE: MANUFACTURING DATES FOR EACH OF THE 2 LOT NUMBERS REPORTED: 24-APR-2024 (PART NUMBER: 72290103/LOT NUMBER: TUG17241) & UNKNOWN (PART NUMBER: 72290097/LOT NUMBER: UNKNOWN). D1: BRAND NAME WAS CHANGED TO UNKNOWN DUE TO THE TWO DEVICES REPORTED: (72290103) TULA CONTROL UNIT SPARE (NST007065) & (72290097) TULA TDS 1.14 GROMMET (STR007011).

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE NUMBER: (B)(4). H3, H6: THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PATIENT COMPLICATION RELATED TO A PRODUCT PROBLEM WITH A SMITH+NEPHEW DEVICE. THE REPORTED ISSUE(S) RELATE TO KNOWN INHERENT DEVICE AND/OR PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED. SMITH+NEPHEW HAS NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON OUR REVIEW OF ALL CURRENTLY AVAILABLE INFORMATION, WE ARE UNABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE. HOWEVER, AS THE USE OF OUR PRODUCT CANNOT BE EXCLUDED AS A POTENTIAL CAUSE OR CONTRIBUTORY FACTOR TO THE REPORTED ISSUE, WE ARE CONSERVATIVELY SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED. D4, LOT NO.: THE FOLLOWING ARE THE PART NUMBERS & LOT NUMBERS OF THE TWO DEVICES REPORTED: PART NUMBER: 72290103/LOT NUMBER: TUG17241, PART NUMBER: 72290097/LOT NUMBER: UNKNOWN. D4, EXP. DATE: EXPIRATION DATES FOR EACH OF THE 2 LOT NUMBERS REPORTED: 18-OCT-2025 (PART NUMBER: 72290103/LOT NUMBER: TUG17241) & UNKNOWN (PART NUMBER: 72290097/LOT NUMBER: UNKNOWN). D4, UNIQUE IDENTIFIER (UDI) #: UNIQUE IDENTIFIER NUMBER FOR EACH OF THE TWO DEVICES REPORTED: (B)(4) (PART NUMBER: 72290103) & (B)(4) (PART NUMBER: 72290097). H11: H2: CORRECTED DATA ON: B1, B2 & H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TYMPANOSTOMY, DURING THE IONTOPHORESIS, THE SURGEON DOUBLE CLICKED ON BOTH CHANNEL BUTTONS TO ENTER "REDUCE MODE" AND THE FAULT INDICATOR LIT UP AND THE CONTROL UNIT STOPPED WORKING. THE SURGEON INSISTED TO USE ANOTHER CONTROL UNIT AND UTILIZED A SPARE TO COMPLETE THE IONTOPHORESIS. AFTER IT WAS COMPLETED, THE SURGEON DEPLOYED THE TUBE DELIVERY SYSTEM IN WHICH A "SHORT SHOT" OCCURRED. THE SURGEON PROMPTLY REMOVED THE TUBE FROM THE EAR CANAL, AND UTILIZED A REPLACEMENT TDS DEVICE. THEY TRIED TO MOVE ON TO THE NEXT EAR AND DUE TO THE PATIENT´S TEMPERAMENT, THE PROCEDURE WAS ABORTED AND RE-SCHEDULED IN THE OPERATING ROOM. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1303729 UNKNOWN TYMPANOSTOMY TUBE DELIVERY PRODUCT WITH DRUG QJA TUSKER MEDICAL INC. UNKNOWN 00885556817742

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| O