MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. ORBERA INTRAGASTRIC BALLOON SYSTEM; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Model Number B-4800

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Abdominal Pain (1685)

Event Date 01/13/2023

Event Type  malfunction  

Event Description

Balloon orbera intragastric balloon system placed [redacted date].Patient complained of abdominal pain [redacted date], found relief with med management.Instructed to call back if no improvement.[redacted date] patient continued to have discomfort, abdominal x-ray ordered and showed orbera intragastric balloon had increased in size.The patient had the balloon removed via endoscopy [redacted date].Model/cat no: b-4800.Manufacturer response for balloon, orbera intragastric balloon system (per site reporter).Similar reports in maude.

• Brand Name: ORBERA INTRAGASTRIC BALLOON SYSTEM
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s capital of tx hwy; bldg 1, ste 300; austin TX 78746
• MDR Report Key: 16528829
• MDR Text Key: 311138106
• Report Number: 16528829
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: B-4800
• Device Catalogue Number: B-4800
• Device Lot Number: S017874910AF05114
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/27/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1