BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NASASTENT

    MDR report key: 11758649 · Received May 1, 2021

    Report

    Report Number
    3006524618-2021-00538
    Event Type
    Injury
    Date Received
    May 1, 2021
    Report Date
    May 24, 2021
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    LYA
    UDI-DI
    00817470004946
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE (B)(4).

    Additional Manufacturer Narrative · 0

    H3, H6 THE REPORTED DEVICE, INTENDED FOR USE TREATMENT, WAS RECEIVED FOR EVALUATION. THERE WAS NO RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. A VISUAL INSPECTION OF THE FOIL POUCH FOUND NO DEFECT TO THE DEVICE PRIMARY PACKING. THE VISUAL INSPECTION OF THE DEVICE INSIDE THE POUCH ALSO DID NOT FIND ANY DEFECT. A FUNCTIONAL EVALUATION FOUND THE NASASTENT DEVICE STAYED IN CONTACT WITH THE WALLS OF THE MODEL THROUGH THE INCUBATION TIME CONFIRMING AT LEAST 72 HOURS RESIDENCE TIME. THE DEVICE ALSO ABSORBED FLUID FROM THE NASAL CHAMBER AND TURNED INTO GEL OVER THE SAME TIME-PERIOD. THE NASASTENT DEVICE THAT HAS TURNED INTO A GEL CAN BE REMOVED FROM THE NASAL MODEL BY SUCTION AND IRRIGATION. THE NASASTENT TESTED MEETS ALL THE REQUIREMENTS OF MINIMUM RESIDENCE TIME, ABSORBS FLUIDS TURNS INTO HYDROCOLLOIDAL GEL, AND CAN BE REMOVED BY SUCTION AND IRRIGATION. A CLINICAL/MEDICAL EVALUATION DETERMINED THAT BASED ON THE INFORMATION PROVIDED VIA E-MAIL SUCH AS THE NOTING THAT THE DRESSING ¿WAS NOT DISSOLVING¿ AND ONLY USING NASAL SPRAY, WE ARE CURRENTLY UNABLE TO RULE OUT A PROCEDURAL VARIANCE AS A CONTRIBUTING FACTOR TO THE REPORTED EVENT, WHICH DOES NOT REPRESENT A DEVICE MALFUNCTION. A COMPLAINT HISTORY REVIEW CONCLUDED THIS WAS A REPEAT ISSUE. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. A REVIEW OF RISK MANAGEMENT FILES FOUND THAT THE REPORTED FAILURE WAS DOCUMENTED APPROPRIATELY. 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. THE COMPLAINT WAS NOT VERIFIED AND THE ROOT CAUSE COULD NOT BE DETERMINED SINCE THE REPORTED MALFUNCTION COULD NOT BE DUPLICATED DURING THE PRODUCT EVALUATION PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, AFTER A FUNCTIONAL ENDOSCOPIC SINUS SURGERY, THE PATIENT WAS COMPLAINING OF A SEVERE PAIN HEADACHE. THE "RAPID RHINO, DISSOLVABLE NASAL DRESSING" WAS NOT DISSOLVING AND HAD TO BE REMOVED BY SUCTION DESPITE A NASAL SPRAY WAS USED FOR 2 WEEKS. THIS ISSUE WAS DETECTED AFTER NASAL SURGERIES AND NO DELAYS, PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED. THE PATIENT RECOVERED FROM PAIN AND HEADACHE AFTER REMOVAL OF THE NASASTENT AND WITHOUT ANY FURTHER TREATMENT.

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT REFERENCE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, AFTER A NASAL SURGERY, THE PATIENT WAS COMPLAINING OF A SEVERE PAIN AND HEADACHE. THE "RAPID RHINO, DISSOLVABLE NASAL DRESSING" WAS NOT DISSOLVING AFTER FOLLOWING HYDRATION GUIDELINES AND TRIMMING METHOD. THIS ISSUE WAS DETECTED AFTER NASAL SURGERIES AND NO DELAYS OR OTHER COMPLICATIONS WERE REPORTED. THE CURRENT STATUS OF THE PATIENT ITS UNKNOWN. 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
    654810 NASASTENT SPLINT, INTRANASAL SEPTAL LYA ARTHROCARE CORP. RR1000 2039143 00817470004946

    Patients

    Seq Age Sex Outcome Treatment
    1 Other