BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORGRIP SR NASOGASTRIC/NASOINTESTINAL FEEDING TUBE RETENTION SYSTEM

    MDR report key: 19919975 · Received August 6, 2024

    Report

    Report Number
    3011270181-2024-00082
    Event Type
    Injury
    Date Received
    August 6, 2024
    Date of Event
    July 15, 2024
    Report Date
    September 5, 2024
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770005638
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD AND UDI ARE IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 05 AUG 2024 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AVANOS MEDICAL INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AVANOS MEDICAL INC. AVANOS MEDICAL INC. HAS NO INDEPENDENT KNOWLEDGE OF THE REPORTED EVENT BUT IS RELAYING THE INFORMATION PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AVANOS MEDICAL INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    PER ADDITIONAL INFORMATION RECEIVED ON 16AUG2024, COMPLICATIONS WERE NOT DUE TO THE DEVICE. THIS COMPLAINT HAS BEEN DOWNGRADED NOT REPORTABLE. NO FURTHER INFORMATION WILL BE SUBMITTED REGARDING THIS INCIDENT. ALL INFORMATION REASONABLY KNOWN AS OF 05 SEP 2024 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AVANOS MEDICAL INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AVANOS MEDICAL INC. AVANOS MEDICAL INC. HAS NO INDEPENDENT KNOWLEDGE OF THE REPORTED EVENT BUT IS RELAYING THE INFORMATION PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AVANOS MEDICAL INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED, "¿WE GOT A NEW PLACEMENT WITH CORGRIP SR BUT THE PATIENT PULLED THE TUBE OUT. WE PUT IN A NEW TUBE APPROXIMATELY 45 MINUTES LATER, BUT FIVE MINUTES AFTER PLACING A NEW TUBE, A BIG BLEEDING STARTED FROM THE NOSE AND MOUTH AND THE OXYGEN SATURATION DROPPED MASSIVELY. THE PATIENT PULLED HIS TUBE / CORGRIP SR AND SINCE HE HAD A DELIRIUM, IT WASN¿T NOTICED THAT HE ALREADY HAD A BLEED. DUE TO THIS BLEEDING, THE PATIENT WAS INTUBATED, HAD A BRONCHOSCOPY AND A TAMPONADE. THE CONDITION OF THE PATIENT UNFORTUNATELY WORSENED SINCE THE BLOOD ALREADY HAD ENTERED THE LUNG." PER ADDITIONAL INFORMATION RECEIVED ON 17JUL2024, ¿PATIENT IS IMPROVING SLOWLY, BUT THEY HOPE TO EXTUBATE THE PATIENT LATER TODAY OR TOMORROW.¿ PER ADDITIONAL INFORMATION RECEIVED ON 18JUL2024, ¿PATIENT WAS EXTUBATED YESTERDAY AND IS DOING FINE.¿

    Description of Event or Problem · 0

    PER ADDITIONAL INFORMATION RECEIVED ON 16AUG2024, "THE HOSPITAL HAS APPROACHED US AND SAID THAT THEY DID THEIR OWN INVESTIGATION, AND THE [EARS, NOSE AND THROAT] ENT SURGEON CAME TO THE CONCLUSION THAT THE COMPLICATION / BLEEDING WAS NOT CAUSED BY CORGRIP SR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1560138 CORGRIP SR NASOGASTRIC/NASOINTESTINAL FEEDING TUBE RETENTION SYSTEM DH CPK CORGRIP TUBE RETENTION KNT AVANOS MEDICAL INC. 26-014 C2460452B 00350770005638

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention| O| L NASOGASTRIC/NASOINTESTINAL TUBE