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 Hemorrhage/Bleeding (1888); Ulceration (2116)

Event Date 03/10/2016

Event Type  Injury  

Manufacturer Narrative

The device labeling addresses the reported event by including ulceration in the list of potential risks.

Event Description

Patient had device inserted (b)(6) 2016 and presented at er on (b)(6) 2016 with hematemesis, diagnosed as upper gi bleeding.The device was retrieved endoscopically.A 2 non-bleeding gastric ulcers (1 anterior, 1 posterior in mid-body) with visible vessel were each treated with a single endoclip.Physician stated that patient's physical exertion level may be a contributing factor to ulcer formation.

• 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: 5561667
• MDR Text Key: 42140984
• Report Number: 3007934906-2016-00005
• 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,Followup
• Report Date: 04/07/2016

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 Expiration Date: 12/16/2016
• Device Model Number: 01-0011-001
• Device Catalogue Number: RSM101
• Device Lot Number: 160105-002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2016
• Initial Date FDA Received: 04/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2016
• 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): Required Intervention
• Patient Age: 30 YR
• Patient Weight: 113