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

Model Number M1-5-1240-I

Device Problems Material Disintegration (1177); Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Date 12/29/2020

Event Type  malfunction  

Event Description

Patient's mother said she inserted the button, filled the balloon with water as she normally does.On the night she noticed the button was loose, so she took the water out of the balloon and refilled it again.The next morning, the button was almost completely out and she took it out and replaced it with her back up.The balloon looked disintegrated, about half of it was missing.

• Brand Name: MINI ONE BALLOON BUTTON
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine blvd; brecksville OH 44141
• MDR Report Key: 11214177
• MDR Text Key: 228174540
• Report Number: 11214177
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M1-5-1240-I
• Device Catalogue Number: M1-5-1240-I
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/08/2021
• Event Location: Home
• Date Report to Manufacturer: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 4380 DA
• Patient Weight: 57