MAUDE Adverse Event Report: OBALON IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Device Problem Insufficient Information (3190)

Patient Problem Perforation of Esophagus (2399)

Event Type  Injury  

Event Description

"during a balloon removal the removing physician perforated the esophagus.The patient was transferred to (b)(6), the perforation repaired surgically and the patient is currently in icu." this report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): OBALON
• MDR Report Key: 17534159
• MDR Text Key: 321097980
• Report Number: MW5141062
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/19/2019

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1