MAUDE Adverse Event Report: RESHAPE LIFESCIENCES RESHAPE INTRAGASTRIC DUAL BALLOON SYSTEM; INTRAGASTRIC BALLOON

Model Number 01-0011-001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nausea (1970); Vomiting (2144)

Event Date 05/23/2018

Event Type  Injury  

Event Description

The balloons were inserted on (b)(6) 2018.The patient was admitted to the emergency room on (b)(6) 2018 complaining of nausea, vomiting, and dehydration; the patient was discharged on (b)(6) 2018.Two days later, the patient was re-admitted to the emergency room and discharged on (b)(6) 2018.The balloon was removed on (b)(6) 2018.

• Brand Name: RESHAPE INTRAGASTRIC DUAL BALLOON SYSTEM
• Type of Device: INTRAGASTRIC BALLOON
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 100 calle iglesia; san clemente CA 92672 7502
• Manufacturer (Section G): RESHAPE LIFESCIENCES; 100 calle iglesia; san clemente CA 92672 7502
• Manufacturer Contact: kristin wielenga ; 100 calle iglesia; san clemente, CA 92672-7502 ; 9492188639
• MDR Report Key: 8185183
• MDR Text Key: 131062595
• Report Number: 3007934906-2018-00039
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: B001RSM1011
• UDI-Public: B001RSM1011
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2020
• Device Model Number: 01-0011-001
• Device Catalogue Number: RSM101
• Device Lot Number: 171030-001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 40 YR