MAUDE Adverse Event Report: RESHAPE LIFESCIENCES RESHAPE DUO BALLOONS; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Device Problem Burst Container or Vessel (1074)

Patient Problem Abdominal Pain (1685)

Event Date 07/01/2019

Event Type  Injury  

Event Description

Reshape duo balloons for weight loss, the balloons burst inside my stomach.The blue dye that was inserted did not show signs of color in my urine.Had terrible stomach pains for months and was told it was normal and i experienced bad odor in urine and a very dark yellow color.This balloon sat in my stomach for 6 months and i notice a problem around 3 months where my appetite increased back and i reported this to the clinic and was told to eat more protein first.I paid $7500 and didn't get any results and not even a replacement.I was told by the dr that reshape duo the company was discontinuing this balloon, and he only had a few left because it was going off market.Went on (b)(6) 2019 to get balloons removed and they informed me that the balloons had burst open and photos was taken and it was reported in my medical records.Fda safety report id# (b)(4).

• Brand Name: RESHAPE DUO BALLOONS
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): RESHAPE LIFESCIENCES
• MDR Report Key: 9224870
• MDR Text Key: 163605595
• Report Number: MW5090562
• Device Sequence Number: 1
• Product Code: KNT
• 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: 10/21/2019

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?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/22/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 100