BEUDAMED
    FDA Adverse Event Injury Summary report: N

    7.5CM ANTERIOR/POSTERIOR

    MDR report key: 11731322 · Received April 27, 2021

    Report

    Report Number
    3006524618-2021-00517
    Event Type
    Injury
    Date Received
    April 27, 2021
    Report Date
    September 14, 2021
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    EMX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3,H6: THE REPORTED DEVICE, USED IN TREATMENT, WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION, THUS VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED AND THUS A COMPLAINT HISTORY REVIEW, MANUFACTURING REVIEW, IFU REVIEW, AND RISK MANAGEMENT REVIEW COULD NOT BE CONDUCTED. A RELATIONSHIP, IF ANY, BETWEEN THE SUBJECT DEVICE AND THE REPORTED EVENT COULD NOT BE DETERMINED. AN ANALYSIS OF THE CUSTOMER PROVIDED IMAGE FOUND THAT THE RAPID RHINO IS INSERTED IN A PATIENTS NOSTRIL. A REVIEW OF THE SINGLE UNDATED, UNLABELED PHOTO PROVIDED APPEARS TO BE A POST-OP PHOTO OF THE PATIENT WITH A PACKING IN THE PATIENT'S RIGHT SWOLLEN NOSTRIL WITH DRIED DARK BLOOD AND THE RAPID RHINO IN PLACE WITH A DELATED BULB. HOWEVER, WITHOUT ADDITIONAL PHOTOS, RELEVANT CLINICAL DOCUMENTATION, I.E., ER NOTES, OFFICE VISIT NOTES, LAB REPORTS, RADIOGRAPHS OR OPERATIVE REPORT THE ROOT CAUSE OF THE REPORTED ISSUE CANNOT BE CONFIRMED. PER THE COMPLAINT, THE CURRENT PATIENT STATUS IS UNKNOWN, AND NO OTHER COMPLICATIONS WERE REPORTED. THEREFORE, THE IMPACT TO THE PATIENT BEYOND THAT WHICH HAS ALREADY BEEN REPORTED CANNOT BE DETERMINED. SHOULD ANY ADDITIONAL MEDICAL INFORMATION BE PROVIDED, THIS COMPLAINT WILL BE RE-ASSESSED. 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

    THE REPORTED DEVICE, USED IN TREATMENT, WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION, THUS VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED AND THUS MANUFACTURING REVIEW. 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 REVIEW OF RISK MANAGEMENT FILES FOUND THAT THE REPORTED FAILURE WAS DOCUMENTED APPROPRIATELY. A COMPLAINT HISTORY REVIEW CONCLUDED THIS WAS AN ISOLATED EVENT. A RELATIONSHIP, IF ANY, BETWEEN THE SUBJECT DEVICE AND THE REPORTED EVENT COULD NOT BE DETERMINED. AN ANALYSIS OF THE CUSTOMER PROVIDED IMAGE FOUND THAT THE RAPID RHINO IS INSERTED IN A PATIENTS NOSTRIL. A REVIEW OF THE SINGLE UNDATED, UNLABELED PHOTO PROVIDED APPEARS TO BE A POST-OP PHOTO OF THE PATIENT WITH A PACKING IN THE PATIENT'S RIGHT SWOLLEN NOSTRIL WITH DRIED DARK BLOOD AND THE RAPID RHINO IN PLACE WITH A DELATED BULB. HOWEVER, WITHOUT ADDITIONAL PHOTOS, RELEVANT CLINICAL DOCUMENTATION, I.E., ER NOTES, OFFICE VISIT NOTES, LAB REPORTS, RADIOGRAPHS OR OPERATIVE REPORT THE ROOT CAUSE OF THE REPORTED ISSUE CANNOT BE CONFIRMED. PER THE COMPLAINT, THE CURRENT PATIENT STATUS IS UNKNOWN, AND NO OTHER COMPLICATIONS WERE REPORTED. THEREFORE, THE IMPACT TO THE PATIENT BEYOND THAT WHICH HAS ALREADY BEEN REPORTED CANNOT BE DETERMINED. SHOULD ANY ADDITIONAL MEDICAL INFORMATION BE PROVIDED, THIS COMPLAINT WILL BE RE-ASSESSED. 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 · 1

    INTERNAL COMPLAINT REFERENCE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RAPID RHINO WAS INSTALLED; THE SURGEON USED A 20CC SYRINGE AND USED ALL THE AIR COMES FROM IT. A CRUNCHING NOISE WAS HEARD. PILOT CUFF WAS HARD LIKE STONE AND PAIN WAS TERRIBLE. THE PATIENT GOT 40 C DEGREES FEVER NEXT DAY. THE PATIENT COMPLAINED ABOUT THE DOCTOR TECHNIQUE INSTEAD OF A DEVICE FAILURE. THE CURRENT PATIENT STATUS IS UNKNOWN. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629827 7.5CM ANTERIOR/POSTERIOR BALLOON, EPISTAXIS EMX ARTHROCARE CORP. RR 750 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention