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

Model Number	M1-5-1417
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Patient's mom noticed patient's button peg was loose.When she checked the balloon, it was broken.

• Brand Name: MINI ONE® BALLOON BUTTON
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine blvd; brecksville OH 44141
• MDR Report Key: 17698165
• Report Number: 17698165
• Device Sequence Number: 6745801
• Product Code: KNT
• UDI-Device Identifier: 00842071100162
• UDI-Public: (01)00842071100162
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/30/2023
• Report Date (Section F): 05/30/2023

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: Health Professional
• Device Model Number: M1-5-1417
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/07/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/07/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 51 KG
• Date Report Sent to FDA: 05/30/2023