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

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

Patient Problems Nausea (1970); Pain (1994); Vomiting (2144); Pressure Sores (2326); Sleep Dysfunction (2517); Weight Changes (2607)

Event Date 02/23/2021

Event Type  malfunction  

Event Description

I had the obrera balloon placed (b)(6) 2021.The same night i had to visit the emergency room for iv zofran and iv fluids.I returned to the doctors office the next day for the same iv therapy.I subsequently had the device removed on (b)(6) 2021 because i was not able to tolerate the device.Any movement caused nausea, vomiting, and pain.I was not able to sleep due to the pain and uncomfortableness of the device and began to develop a stage one pressure ulcer.There was only one position that i could be in that was somewhat tolerable.Ambulation of more than 3 feet caused nausea and vomiting as well as pain.Talking caused nausea and vomiting.I was not able to keep any substances down.For the week i had the device, i only had water, some gatorade (maybe 20 oz.), and 6 oz.Of a protein shake.The shake and gatorade were later vomited.I lost a total of 14 lbs.In that week due to my inability to intake any sort of nutrition.Fda safety report id# (b)(4).

• Brand Name: ORBERA BALLOON
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): APOLLO ENDOSURGERY INC
• MDR Report Key: 11596051
• MDR Text Key: 243464096
• Report Number: MW5100421
• Device Sequence Number: 1
• Product Code: LTI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/28/2021

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?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/30/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR
• Patient Weight: 101