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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Pain (1994); Perforation (2001)

Event Date 02/23/1962

Event Type  Death  

Event Description

Received voluntary medwatch (mw5071866) reporting: "this consumer voluntary report is submitted on behalf of a patient who had the orbera gastric balloon placed on or about (b)(6) 2017 by (b)(6) of (b)(6).Either in his office or at (b)(6).The patient reported severe pain to the treating physician and had emergent surgery on or about (b)(6) 2017 at (b)(6) for removal of the balloon and repair of a perforation of the stomach wall.The patient continued to suffer from complications from the perforation, infection and surgical repair, undergoing subsequent surgical intervention and was transferred to (b)(6) for life-threatening complications on or about (b)(6) 2017.The patient expired on (b)(6) 2017." follow up findings with the physician: the patient was not implanted with an orbera device.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ORBERA GASTRIC BALLOON
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC
• MDR Report Key: 17528433
• MDR Text Key: 321043316
• Report Number: MW5135363
• 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: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1