BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIEVA TRACT BALLOON DILATION SYSTEM, 16X40MM - 1PK

    MDR report key: 19105775 · Received April 15, 2024

    Report

    Report Number
    3005172759-2024-00028
    Event Type
    Injury
    Date Received
    April 15, 2024
    Date of Event
    March 1, 2024
    Report Date
    April 15, 2024
    Manufacturer
    ACCLARENT, INC.
    Product Code
    QGK
    UDI-DI
    10705031462649
    PMA / PMN Number
    K183090
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER AND GENDER WERE NOT PROVIDED. D.4: THE EXPIRATION DATE OF THE DEVICE IS NOT KNOWN AS THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. H.4: THE DEVICE MANUFACTURE DATE IS NOT KNOWN AS THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. BASED ON COMPLAINT INFORMATION, THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. THE DEVICE LOT NUMBER WAS NOT AVAILABLE. THE MANUFACTURING DOCUMENTATION REVIEW COULD NOT BE PERFORMED WITHOUT THE LOT NUMBER. SINCE THIS ADVERSE EVENT REQUIRED HOSPITALIZATION OF THE PATIENT AND DIAGNOSTIC INTERVENTION TO EXCLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS CONSIDERED SERIOUS AND REPORTABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS CASE WILL BE RE-ASSESSED AND NOTES WILL BE UPDATED. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE / PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ACCLARENT, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ACCLARENT, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WHO UNDERWENT ENT (EAR, NOSE & THROAT) PROCEDURE WITH ACCLARENT DEVICES ON (B)(6) 2024 EXPERIENCED BRUISING AND SWELLING BELOW THE EYES AND SWELLING AROUND THE LOWER JAW. IT WAS ALSO REPORTED THAT THE PHYSICIAN HAD ADMITTED THE PATIENT FOR A POST-OP CT SCAN, AND IT WAS CONFIRMED THAT THERE WAS NO CRIBRIFORM PLATE FRACTURE PRESENT. THE CALLER REPORTED THAT THERE WAS NO OTHER MEDICAL INTERVENTION PROVIDED TO THE PATIENT. THE CALLER REPORTED THAT THE PATIENT IS IN STABLE CONDITION. THERE ARE NO REPORTED MALFUNCTIONS WITH ANY ACCLARENT DEVICES USED DURING THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836549 RELIEVA TRACT BALLOON DILATION SYSTEM, 16X40MM - 1PK BALLOON, NASAL AIRWAY QGK ACCLARENT, INC. 10705031462649

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization