MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY, INC. AMT MINIACE CECOSTOMY BUTTON; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Device Problems Leak/Splash (1354); Unintended Deflation (4061)

Patient Problem Failure of Implant (1924)

Event Date 08/22/2022

Event Type  malfunction  

Event Description

Balloon on her amt mini ace button was leaking and had completely deflated.Fda safety report id# (b)(4).

• Brand Name: AMT MINIACE CECOSTOMY BUTTON
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC.
• MDR Report Key: 15380746
• MDR Text Key: 299704132
• Report Number: MW5111935
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other