MAUDE Adverse Event Report: APOLLO ENDOSURGERY INC. LAPBAND; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Device Problems Material Erosion (1214); Migration or Expulsion of Device (1395); Device Slipped (1584)

Patient Problems Chest Pain (1776); Gastritis (1874); Vomiting (2144); Foreign Body In Patient (2687)

Event Date 03/12/2018

Event Type  Injury  

Event Description

My lap band had slipped, eroded in my stomach and embedded into my liver causing, vomiting, gerd and extreme chest pain.

• Brand Name: LAPBAND
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): APOLLO ENDOSURGERY INC.
• MDR Report Key: 8277835
• MDR Text Key: 134357150
• Report Number: MW5083378
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/24/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 36 YR
• Patient Weight: 82