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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 Defective Device (2588); Physical Resistance/Sticking (4012)
Patient Problem Unspecified Infection (1930)
Event Date 03/10/2021
Event Type  Injury  
Event Description
During percutaneous gastrostomy tube placement, t-tracks were used, 1/3 fasteners did not dissolve or fall into the stomach and passed as expected.The t-track adhered to patient's abdomen and became source for methicillin-resistant staphylococcus aureus (mrsa) infection.The t-track was surgically removed.
 
Event Description
During percutaneous gastrostomy tube placement, t-tracks were used, 1/3 fasteners did not dissolve or fall into the stomach and passed as expected.The t-track adhered to patient's abdomen and became source for methicillin-resistant staphylococcus aureus (mrsa) infection.The t-track was surgically removed.
 
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Brand Name
AVANOS
Type of Device
TUBE, GASTRO-ENTEROSTOMY
Manufacturer (Section D)
AVANOS MEDICAL, INC.
5405 windward parkway
alpharetta GA 30004
MDR Report Key12810568
MDR Text Key280749106
Report Number12810568
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 Risk Manager
Type of Report Initial,Followup
Report Date 11/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model Number98701
Device Catalogue Number98701
Device Lot Number3008519
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/10/2021
Event Location Hospital
Date Report to Manufacturer11/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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