MAUDE Adverse Event Report: OBALON THERAPEUTICS INC. OBALON BALLOON; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Model Number 7600-0001

Device Problem Positioning Problem (3009)

Patient Problems Abdominal Pain (1685); Fatigue (1849); Pain (1994); No Code Available (3191); Constipation (3274)

Event Date 04/20/2018

Event Type  Injury  

Event Description

On (b)(6) 2018 i had the third obalon balloon placed and it was okay for the first few days but within a week i began experiencing extreme reflux that i had not had before and was prescribed protonics twice a day without any relief.Additionally, the third balloon began to feel as if it was constantly under my ribs and in a too high position which caused extreme pain.I began to constantly push down on the upper right side of my abdomen trying to push the balloon down and i had to sleep on my left side in hopes of getting the balloon to move down.Often at night i remained awake for hours belching (painfully) trying to get relief.Until this event, the only history i had with reflux was years before when i took too many nsaids and developed a small ulcer.I stopped taking nsaids and i had not further complications.After the placement of the third balloon, i also experienced increased problems with my pre-existing problem of constipation.I became extremely constipated several times and had a difficult time clearing out the stool and getting it to move around the balloons.Anyway, the feeling of the third balloon pushing on my diaphragm continued to worsen.It felt just like i was 5 months pregnant again and my baby was pushing up under my ribs.It was the same kind of pain for several weeks after the third balloon was placed.Please note i'm barely 5'2" so short in stature.I was also barely able to eat anything because of the terrible reflux and the increased pain it would cause to eat even the tiniest amount of food.I reported these symptoms to during my monthly appointment with the dietician at ultimate bariatrics.She gave me suggestions for handling the symptoms and tried to live with them for about another week.However, on (b)(6) 2018, the pain in the upper right quadrant of my abdomen became much worse and the balloon seemed "stuck" up under my right ribs and pushing on it no longer relieved the pain.I put up with it for another 24 hours but i did make an appointment with my doctor for the morning of (b)(6) 2018.By my appointment i could no longer drive myself due to the pain.My husband drove me to my appointment where a x-ray of the balloons was taken.To me, it looked like one of the balloons (possibly the third) had moved up too high.I definitely was not in the same position it was when i initially swallowed it.Luckily, my surgeon was already working at an ambulatory surgery center in hurst, tx.They had me go straight from the ft.Worth office of ultimate bariatrics to the surgicenter where i was taken quickly into surgery and the balloons were removed.My doctor was very responsive.However, my op permit said the balloons were being removed due to fatigue.I guess that is true, i was tired of the extreme pain.My doctor also told my husband i had reflux before and the balloons made it worse, as a reason for my complications.That is also true, but no one addressed that the balloon felt like it was constantly pushing on my diaphragm to the point i had to constantly hold it down with my hand to get any relief.Once the balloons were out, the relief was immediate, though my diaphragm had an ache to it for several days afterward from where the balloon had been pushing on the right upper side.I have also had no reflux and no need for protonix since the balloons were removed.I have the info on the 3 balloons (ref number, lot number, serial numbers).

• Brand Name: OBALON BALLOON
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): OBALON THERAPEUTICS INC.
• MDR Report Key: 7472341
• MDR Text Key: 107021165
• Report Number: MW5076862
• Device Sequence Number: 2
• Product Code: LTI
• Combination Product (y/n): N
• 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: 04/25/2018
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 7600-0001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/27/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 70