MAUDE Adverse Event Report: APOLLO ENDOSURGERY ORBERA INTRAGASTRIC BALLOON

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Abdominal Pain (1685); Dehydration (1807); Hemorrhage/Bleeding (1888); Nausea (1970); Pneumonia (2011); Vomiting (2144); Ulcer (2274); Complaint, Ill-Defined (2331)

Event Date 04/20/2016

Event Type  Injury  

Event Description

The balloon was placed on (b)(6) 2016 early morning, by night time i was having extreme stomach pain.I was admitted to the hospital the next day for nausea, vomiting, brown emesis, and dehydration and stomach pain.The doctor refused to remove balloon by saturday night/sunday morning i had ards aspiration pneumonia and gi bleed.I was transferred to (b)(6) where i was put on ecmo.I stayed 72 days at (b)(6).Ecmo saved my life.The balloon caused major ulcers.I ended up with more than 30 units of blood.My stomach look like road rash.I was given a ten percent of survival.I will forever have side effects from stomach and lung damage.

• Brand Name: ORBERA INTRAGASTRIC BALLOON
• Type of Device: ORBERA INTRAGASTRIC BALLOON
• Manufacturer (Section D): APOLLO ENDOSURGERY
• MDR Report Key: 6812714
• MDR Text Key: 83500998
• Report Number: MW5071748
• Device Sequence Number: 1
• 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: 08/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/23/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Weight: 74