MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY, INC. MINI ONE BALLOON BUTTON ; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	M151208
Health Effect - Clinical Code	Skin Irritation (2076)
Date of Event	02/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Infant noted to have redness around gtube.While feeding was running, noted leakage around the gtube and it came out.When verified the balloon, noted to have tear and not inflating.Fda safety report id# (b)(4).

• Brand Name: MINI ONE BALLOON BUTTON
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC.
• MDR Report Key: 9707137
• Report Number: MW5092990
• Device Sequence Number: 355579
• Product Code: KNT
• UDI-Device Identifier: 00842071100001
• UDI-Public: 00842071100001
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: M151208
• Device Catalogue Number: M1-5-1208
• Device Lot Number: 10447607
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/12/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 3 MO
• Patient Weight: 3