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

Model Number 01-00011-001

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

Patient Problems Inflammation (1932); Nausea (1970); Vomiting (2144)

Event Date 01/12/2017

Event Type  Injury  

Event Description

Device was inserted without issue on (b)(6) 2016.Patient contacted implanting physician on 1/10/2017 reporting nausea and vomiting.On (b)(6) 2017, patient was admitted to the hospital with recurrent nausea, vomiting, and dehydration in the context of refractory gerd.Implanting physician also diagnosed patient as having hypokalemia.Patient requested that the device be removed and removal was completed on (b)(6) 2017.On the same day, post-removal, patient spiked a fever and was diagnosed with aspiration pneumonitis.Patient was treated overnight with iv antibiotics and discharged on (b)(6) 2017 with oral antibiotics.

• Brand Name: RESHAPE INTEGRATED DUAL BALLOON SYSTEM
• 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: 6295148
• MDR Text Key: 66315354
• Report Number: 3007934906-2017-00005
• 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: 02/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Model Number: 01-00011-001
• Device Catalogue Number: RSM101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2017
• Initial Date FDA Received: 02/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 59 YR