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

Model Number	M1-5-1417
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is a response to mdr report # (b)(4) which was received by amt from the fda on 09/07/2023.Based on the provided information, the complaint is not a reportable event per 21 cfr section 803.There was no death.There was no serious injury, as defined by the fda.This was not life-threatening, nor did this result in permanent impairment or necessitate medical or surgical intervention to preclude permanent impairment.There was no indication of the device being available for return.Amt is currently trying to work with the reporter to see if the device can be obtained for examination.Since the device was not returned, a visual and functional evaluation could not be performed and the device failure cannot be confirmed at this time.The complaint information has been logged into our complaint database for trending purposes.Complaint # (b)(4) was assigned to this report.
Event or Problem Description
Per the original reporter in uf/importer report #: (b)(4), "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 boulevard; brecksville OH 44141
• Manufacturer (Section G): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine boulevard; brecksville OH 44141
• Manufacturer Contact: joshua meinke ; 8006 katherine boulevard; brecksville, OH 44141 ; 4407174000
• MDR Report Key: 17887314
• Report Number: 1526012-2023-00007
• Device Sequence Number: 17884064
• Product Code: KNT
• UDI-Device Identifier: 00842071100162
• UDI-Public: 00842071100162
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K161413
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/06/2023

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
• Device Catalogue Number: M1-5-1417
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 10/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 23 YR
• Patient Sex: Male
• Patient Weight: 51 KG