MAUDE Adverse Event Report: APOLLO ENDOSURGERY COSTA RICA S.R.L. LAP BAND; IMPLANT, INTRAGASTRIC, FOR MORBID OBESITY

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

Patient Problem No Code Available (3191)

Event Date 09/27/2019

Event Type  Injury  

Event Description

Had a lap band put in approx (b)(6) 2002, due to various increasing problems.I had to have it removed in (b)(6) 2019.The main one was that the restriction from the band was causing gerd and causing stomach acid to end up in my lungs.Fda safety report id# (b)(4).

• Brand Name: LAP BAND
• Type of Device: IMPLANT, INTRAGASTRIC, FOR MORBID OBESITY
• Manufacturer (Section D): APOLLO ENDOSURGERY COSTA RICA S.R.L.
• MDR Report Key: 9172507
• MDR Text Key: 161807540
• Report Number: MW5090296
• 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: 10/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 48 YR
• Patient Weight: 132