MAUDE Adverse Event Report: RESHAPE RESHAPE BALLOON SYSTEM (INTEGRATED DUAL); IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Vomiting (2144); Dizziness (2194); Rupture (2208); Complaint, Ill-Defined (2331); Perforation of Esophagus (2399); Loss of consciousness (2418)

Event Date 03/11/2017

Event Type  Injury  

Event Description

I got the reshape balloon inserted on (b)(6).I felt bad but not any worse than i read.On (b)(6), i woke up in the middle of the night dizzy and trying to get to the bathroom to throw up.I fell on my bathroom floor because i passed out.I opened my eyes and i started throwing up blood.It also started coming out of my nose.I told my husband to call 911.Got to hospital, they had to do surgery to remove balloons.The vessels at the bottom of my esophagus ruptured and they cauterized them.I ended up staying the night.

• Brand Name: RESHAPE BALLOON SYSTEM (INTEGRATED DUAL)
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): RESHAPE
• MDR Report Key: 6794138
• MDR Text Key: 82792954
• Report Number: MW5071576
• 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: 08/11/2017

1 Device was Involved in the Event

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/11/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 34 YR
• Patient Weight: 103