MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY, INC. MINI ONE; LOW PROFILE GASTROSTOMY BALLOON BUTTON

Model Number	M1-5-1212-I
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is a response to uf report # (b)(4) which was received by amt from the fda on 09/14/2023.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.Amt is attempting to work with the reporter to gather additional information regarding the complaint and to confirm that the device is not available for return.Since the device has not been returned, a visual and functional evaluation could not be performed, and device failure could not be confirmed.The device was reportedly in use for at least 8-9 months before the failure occurred.Based on the provided information, the reported complaint is not believed to have been caused by a manufacturing defect.We will continue to try and work with the original reporter to obtain the device in question and additional information if available.
Event or Problem Description
Per the original reporter in uf/impoter report #: (b)(4), "leakage from the connecting port was noted on the patient's blanket.Upon inspection, a crack was discovered at the port.".

• Brand Name: MINI ONE
• Common Device Name: LOW PROFILE GASTROSTOMY BALLOON BUTTON
• 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: 18445947
• Report Number: 1526012-2023-00010
• Device Sequence Number: 20553781
• Product Code: KNT
• UDI-Device Identifier: 00842071113834
• UDI-Public: 00842071113834
• 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
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/13/2023

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
• Device Expiration Date: 09/01/2025
• Device Model Number: M1-5-1212-I
• Device Catalogue Number: M1-5-1212-I
• Device Lot Number: 221007-349
• 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: 09/14/2023
• Initial Report FDA Received Date: 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2022
• 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: 14 MO
• Patient Sex: Male
• Patient Weight: 8 KG
• Patient Ethnicity: Hispanic