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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AVANOS MEDICAL, INC. HALYARD TUBE, GASTRO-ENTEROSTOMY

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AVANOS MEDICAL, INC. HALYARD TUBE, GASTRO-ENTEROSTOMY Back to Search Results
Model Number 98433
Device Problems Leak/Splash (1354); Component Missing (2306); Device Dislodged or Dislocated (2923)
Patient Problems Erythema (1840); Sleep Dysfunction (2517)
Event Date 01/10/2019
Event Type  malfunction  
Event Description
Cancer of nasopharynx on chemotherapy cisplatin and radiation therapy. Patient had a peg tube placed in abdomen in december. Patient asked to be seen today in radiation with complaint of abdominal dressing very wet covering the peg tube. I had the rn remove the dressing with the intent to redo it but when the rn removed the dressing the g-tube was sitting in the dressing completely out of the patient's stomach as the tube had come dislodged at some point. Patient sleeps on his abdomen at night. At one point the patient had 4, of what the physician who placed the 2 called tacks. They look like little buttons, but there are only 2 currently, one almost detached and the second one very secured to the abdomen. There were no other notable tubes there. Patient also has significant erythema around one of the areas. I am uncertain how the abdomen is going to look once that is removed. Patient has not been using the tube but primarily has been flushing it. Patient otherwise seemingly is tolerating treatment reasonably well. Plan is to reinsert feeding tube tomorrow. The next day the patient refused replacement of g-tube today as scheduled. Patient did not want it put back in due to placement interfering with sleep, etc. Provider had a long discussion with the patient about risks of not replacing as the patient is going through therapy and the patient was informed that if they change their mind at any time it could be rescheduled. All remaining buttons removed, clean dressing applied to site and patient instructed to keep covered.
 
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Brand NameHALYARD
Type of DeviceTUBE, GASTRO-ENTEROSTOMY
Manufacturer (Section D)
AVANOS MEDICAL, INC.
5405 windward parkway
alpharetta GA 30004
MDR Report Key8319830
MDR Text Key135518621
Report Number8319830
Device Sequence Number1
Product Code KGC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/28/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number98433
Device Catalogue Number98433-03
Device Lot NumberAA8232R10
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/28/2019
Event Location Other
Date Report to Manufacturer02/08/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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