MAUDE Adverse Event Report: RESHAPE MEDICAL RESHAPE INTEGRATED DUAL BALLOON SYSTEM; INTRAGASTRIC BALLOON

Model Number	01-0011-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aspiration/Inhalation (1725); Dehydration (1807); Vomiting (2144)
Date of Event	07/02/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
The balloon ws inserted on (b)(6) 2018.Post insertion, the patient was admitted twice to the hospital, the first time for dehydration and the second time for aspiration pneumonia.On (b)(6) 2018, the patient was advised by their physician to return to the emergency room for another dehydration treatment.The patient was advised that the balloon may have caused the aspiration pneumonia and was prescribed reflux medication.The patient continued to vomit on a regular basis and is scheduled for a follow up visit with their physician pending the dehydration treatment which would likely lead to a removal.The patient expressed they would like to leave the balloon in and possibly filling the balloon less.

• Brand Name: RESHAPE INTEGRATED DUAL BALLOON SYSTEM
• Common Device Name: INTRAGASTRIC BALLOON
• Manufacturer (Section D): RESHAPE MEDICAL; 100 calle iglesia; san clemente CA 92672 7502
• MDR Report Key: 7731711
• Report Number: 3007934906-2018-00027
• Device Sequence Number: 1618302
• Product Code: LTI
• UDI-Device Identifier: B001RSM1011
• UDI-Public: B001RSM1011
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P140012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2018

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
• Operator of Device: Health Professional
• Device Model Number: 01-0011-001
• Device Catalogue Number: RSM101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2018
• Initial Report FDA Received Date: 07/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization