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

Model Number	M151210
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/05/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Gtube noted to be out during cares.Old gtube assessed and was found to be all intact except for a hole on the balloon.Slight tear noted to the top of the balloon.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: 9707153
• Report Number: MW5092991
• Device Sequence Number: 355581
• Product Code: KNT
• UDI-Device Identifier: 00842071100018
• UDI-Public: 00842071100018
• 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: M151210
• Device Lot Number: 10435664
• 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: 6 MO
• Patient Weight: 6