MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY, INC. MINIONE BALLOON BUTTON; LOW PROFILE FEEDING DEVICE

Model Number	M1-5-1412-I
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is a response to medsun report #(b)(4) which was received by amt from the fda on 02/13/2026.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.Amt reached out to the reporter to gather additional information regarding the complaint and to see if the device is available for return.At the time of this report there has been no response to the availability of the device.Due to this, a visual and functional evaluation could not be performed, and device failure could not be confirmed.If the device is returned at a later date, device examination will not change the non-reportability of this complaint.Based on the provided information, the reported complaint is not believed to have been caused by a manufacturing defect.Note, the reported lot number, 260930-355, does not match any production records.Review of production records found that lot number 250930-355 does match a m1-5-1412-i manufacturing lot.It is believed this was the intended lot to be reported.A device history review was completed for lot number 250930-355.No anomalies were found and there have been no other complaints from this same batch.The complaint information has been logged into our complaint database for trending purposes.Complaint #(b)(4) was assigned to this report for internal trending.
Event or Problem Description
Per the original reporter in medsun report #: (b)(4), it was reported that the, "patient with gastrostomy tube (gt) button placed [redacted], button ruptured and dislodged from patient on [redacted]-70 days later.Rn replaced with new gt button tube.No harm to patient".

• Brand Name: MINIONE BALLOON BUTTON
• Common Device Name: LOW PROFILE FEEDING DEVICE
• 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: ellyn dipaolo ; 8006 katherine boulevard; brecksville, OH 44141 ; 4402622539
• MDR Report Key: 24777061
• Report Number: 1526012-2026-00007
• Device Sequence Number: 12295588
• Product Code: KNT
• UDI-Device Identifier: 00842071140793
• UDI-Public: 00842071140793
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 04/03/2026

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: M1-5-1412-I
• Device Catalogue Number: M1-5-1412-I
• Device Lot Number: 250930-355
• 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: 02/13/2026
• Initial Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 7 MO
• Patient Sex: Male
• Patient Weight: 5 KG