MAUDE Adverse Event Report: RESHAPE MEDICAL, INC. RESHAPE INTEGRATED DUAL BALLOON; INTRAGASTRIC BALLOON

Model Number 01-0011-001

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

Patient Problems Fever (1858); Perforation (2001); Ulceration (2116); Abdominal Cramps (2543)

Event Date 06/03/2016

Event Type  Injury  

Manufacturer Narrative

Event Description

The device was inserted without issue on (b)(6) 2016.Patient contacted the treating physician on (b)(6) 2016 reporting abdominal cramping and high fever.The patient was admitted to the hospital on (b)(6) 2016 and ct scan confirmed a small perforation in the stomach.The balloon was endoscopically removed on (b)(6) 2016, at which time the physician noted a 1cm superficial ulcer with an approximate 2mm perforation.The location of the ulcer was "at the greater curvature at the anterior/ upper body/ proximal portion" of the stomach.The perforation was repaired with a suture and an imbrication stitch.The perforation was also patched with omentum and covered with fibrin glue.Patient was discharged on (b)(6) 2016 without further issue.

• Brand Name: RESHAPE INTEGRATED DUAL BALLOON
• Type of Device: INTRAGASTRIC BALLOON
• Manufacturer (Section D): RESHAPE MEDICAL, INC.; 100 calle iglesia; san clemente CA 92672 7502
• Manufacturer (Section G): RESHAPE MEDICAL, INC.; 100 calle iglesia; san clemente CA 92672 7502
• Manufacturer Contact: greg geissinger ; 100 calle iglesia; san clemente, CA 92672-7502 ; 9494296680
• MDR Report Key: 5800595
• MDR Text Key: 49746314
• Report Number: 3007934906-2016-00017
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/13/2017
• Device Model Number: 01-0011-001
• Device Catalogue Number: RSM101
• Device Lot Number: 160323-006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2016
• 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