MAUDE Adverse Event Report: UNKNOWN IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Device Problem Device Slipped (1584)

Patient Problems Dysphagia/ Odynophagia (1815); Obstruction/Occlusion (2422); Prolapse (2475)

Event Type  Injury  

Event Description

Per received patient's op report, "(b)(6) 2006 - lagb prolapse and relief of obstruction with reposition and replacement.Over the last six months, experiencing difficulty swallowing." this event is against a non-apollo device.(b)(6).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17533713
• MDR Text Key: 321147918
• Report Number: MW5140617
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1