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U.S. Department of Health and Human Services

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

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AVANOS MEDICAL, INC. AVANOS TUBE, GASTRO-ENTEROSTOMY Back to Search Results
Model Number 98701
Device Problems Entrapment of Device (1212); Migration (4003)
Patient Problems Foreign Body In Patient (2687); Skin Inflammation/ Irritation (4545)
Event Date 02/10/2022
Event Type  malfunction  
Event Description
Updating to add original procedure date. Patient had foreign body removed from abdominal wound during wound clinic visit. Entering midas to report product to fda/medsun. Product was discovered to be t-faster utilized during g-tube placement. This appears to be a rare complication where the t-fastener migrated through the stomach and into the skin where it caused an irritation. Product is meant to be passed out through the intestinal tract after sutures are released/dissolved.
 
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Brand NameAVANOS
Type of DeviceTUBE, GASTRO-ENTEROSTOMY
Manufacturer (Section D)
AVANOS MEDICAL, INC.
5405 windward parkway
alpharetta GA 30004
MDR Report Key14120349
MDR Text Key289437716
Report Number14120349
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
Type of Report Initial
Report Date 04/05/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number98701
Device Catalogue Number98701
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/05/2022
Device Age7 MO
Event Location Other
Date Report to Manufacturer04/15/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Type of Device Usage Unkown

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