BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XOM UNKNOWN ENDO

    MDR report key: 4348348 · Received December 19, 2014

    Report

    Report Number
    1045254-2014-00336
    Event Type
    Injury
    Date Received
    December 19, 2014
    Report Date
    November 26, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE IS BEING REPORTED FROM A LITERATURE REVIEW. NO DEVICES WILL BE RETURNED, THEREFORE NO EVALUATION COULD BE PERFORMED. . THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.

    Description of Event or Problem · 1

    FROM THE ARTICLE PUBLISHED IN THE JOURNAL "ENT ¿ EAR, NOSE <(>&<)> THROAT JOURNAL" IN SEPTEMBER 2014 ENTITLED "COMPARATIVE STUDY OF INTRANASAL SEPTAL SPLINTS AND NASAL PACKS IN PATIENTS UNDERGOING NASAL SEPTAL SURGERY,¿ BY RAMAN WADHERA, MS; NAUSHAD ZAFAR, MS; SAT PAUL GULATI, MS; VIJAY KALRA, MS; ANJU GHAI, MD. IT WAS REPORTED THAT THE MEDTRONIC REUTER BIVALVE INTRANASAL SPLINT WAS USED AFTER SEPTOPLASTY PROCEDURES FOR 30 PATIENTS WITH A SYMPTOMATIC DEVIATION OF THE NASAL SEPTUM. THE MEDTRONIC REUTER BIVALVE INTRANASAL SPLINT PATIENTS WERE ONLY 1 OF 2 GROUPS IN THE STUDY, WHICH CONSISTED OF 25 MALES AND 5 FEMALES WITH A MEAN AGE OF 23.3 YEARS. THE PATIENTS WERE ASSESSED FOR PAIN, DISCOMFORT AND COMPLICATIONS POSTOPERATIVELY AT 24 AND 48 HOURS, 1 WEEK AND 6 WEEKS (NOTE: AT 6 WEEKS, PATIENTS WERE ASKED FOR THEIR SUBJECTIVE ASSESSMENT OF COMPLAINTS AND WERE ALSO EXAMINED ENDOSCOPICALLY). BASED ON THESE FACTORS, THE FOLLOWING COMPLICATIONS WERE IDENTIFIED POSTOPERATIVELY AFTER 48 HOURS: NASAL BLEEDING (3 PATIENTS), SWELLING OVER THE FACE AND NOSE (3 PATIENTS), NASAL DISCHARGE (2 PATIENTS), NASAL OBSTRUCTION (7 PATIENTS), FEEDING DIFFICULTY (2 PATIENTS), TIP CELLULITIS (10 PATIENTS)¿AND THE FOLLOWING COMPLICATIONS WERE IDENTIFIED POSTOPERATIVELY AT 6 WEEKS: RESIDUAL DEFORMITY (2 PATIENTS) AND NASAL DISCHARGE (4 PATIENTS). THESE PATIENT INJURIES ARE A LL KNOWN COMPLICATIONS IN SEPTOPLASTY PROCEDURES RECOGNIZED BY THE ARTICLE. IT WAS ALSO CONCLUDED THAT THE MEDTRONIC REUTER BIVALVE INTRANASAL SPLINTS RESULT IN LESS POSTOPERATIVE PAIN WITHOUT INCREASING POSTOPERATIVE COMPLICATIONS, AND IN ADDITION TO THE EASE, EFFECTIVENESS, AND SAFETY OF SPLINTING ¿ MAKE IT A SUPERIOR ALTERNATIVE TO NASAL PACKING AFTER SEPTAL SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835425 XOM UNKNOWN ENDO EQJ MEDTRONIC XOMED INC. XOM UNKNOWN ENDO NI

    Patients

    Seq Age Sex Outcome Treatment
    1