BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TYMPANIC MEMBRANE PATCHER 1416010 5MM

    MDR report key: 2860940 · Received December 6, 2012

    Report

    Report Number
    1045254-2012-00697
    Event Type
    Injury
    Date Received
    December 6, 2012
    Report Date
    November 6, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KHJ
    PMA / PMN Number
    K964484
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THIS COMPLAINT IS BEING FILED AS A RESULT OF A LITERATURE REVIEW. NO PRODUCT WILL BE RETURNED FOR EVALUATION. THE DEVICE WAS NOT RETURNED AND THEREFORE NO EVALUATION COULD BE PERFORMED. THE FOLLOWING CODES WERE NOT AVAILABLE IN MEDTRONIC'S GCH SYSTEM: METHOD: ACTUAL DEVICE NOT EVALUATED. RESULTS: NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED. CONCLUSION: DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    A LITERATURE REVIEW OF AN ARTICLE PUBLISHED IN THE JOURNAL "THE AMERICAN JOURNAL OF OTOLOGY, INC." 2000 ENTITLED "TYMPANIC MEMBRANE PATCHER: A NEW DEVICE TO CLOSE TYMPANIC MEMBRANE PERFORATIONS IN AN OFFICE SETTING, BY JACK M. KARTUSH, DEPARTMENT OF OTOLOGY AND NEUROTOLOGY, PROVIDENCE HOSPITAL, SOUTHFIELD, MICHIGAN REVEALED A STUDY INVOLVING TYMPATHIC MEMBRANE PATCHERS IN WHICH SEVERAL PATIENTS REQUIRED MEDICAL INTERVENTION. NO SPECIFIC PATIENT INFORMATION IS AVAILABLE. THE FOLLOWING EVENTS WERE REPORTED: THREE PATIENTS HAD RARE OTORRHEA AFTER PATCHING AND WERE TREATED BY DROPS OR TEMPORARY REMOVAL OF THE PATCHER. TWO OF THESE THREE EARS SUBSEQUENTLY BECAME DRY AND THEN HEALED. ONE HAD DYSFUNCTION OF THE EUSTACHIAN TUBE AFTER RADIATION THERAPY AND HAD TWO EPISODES OF OTORRHEA TREATED BY DROPS AND, ON ONE OCCASION, TEMPORARY REMOVAL OF THE PATCHER FOR 2 WEEKS. AFTER REPATCHING, THE PERFORATION HEALED. TWO PATIENTS WITH PERSISTENT DRAINAGE WERE TAKEN TO SURGERY AND WERE FOUND TO HAVE MASTOID DISEASE (CHOLESTEATOMA OR GRANULATION TISSUE). THE PATCHER REQUIRED REPLACEMENT OR REPOSITIONING IN EIGHT PATIENTS BECAUSE OF LATERALIZATION OR TRANSIENT OTORRHEA. THE PATCHER WAS REMOVED IN SIX PATIENTS BECAUSE THE EAR REMAINED WET OR BECAUSE THE PATIENT SUBSEQUENTLY ELECTED TO UNDERGO SURGERY. IN ONE CHILD IN WHOM TYMPANOPLASTY HAD FAILED, OTORRHEA OCCURRED ONCE AND WAS RESOLVED WITH ANTIBIOTIC DROPS. NOTE: NO PART NUMBERS OR LOTS WERE PROVIDED IN THE ARTICLE. PART NUMBER 1416010 (TYMPANIC MEMBRANE PATCHER 5MM) WAS ASSIGNED TO THIS COMPLAINT FOR DATA ENTRY PURPOSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TYMPANIC MEMBRANE PATCHER 1416010 5MM TUBE, TYMPANOSTOMY KHJ MEDTRONIC, INC. 1416010 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention