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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Chest Pain (1776); Pain (1994); Vomiting (2144); Burning Sensation (2146)

Event Date 07/01/2019

Event Type  Injury  

Event Description

I had a lap band placed in (b)(6) 2011.After years of suffering i had it removed (b)(6) 2019.I endured constant 24/7 forced hard burping that perform from living a normal existence.I endured reflux and port pain, burning and stinging.I puked almost daily with gripping chest pain.Bard does not help aid in weight loss after a year.It was worst thing i ever did to myself.The makers of these bands should be held accountable for the pain and suffering people endure from them.So unhealthy.Fda safety report id# (b)(4).

• Brand Name: LAP-BAND ADJUSTABLE GASTRIC BAND
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): APOLLO ENDOSURGERY COSTA RICA S. R. L.
• MDR Report Key: 8879280
• MDR Text Key: 153975951
• Report Number: MW5088910
• 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: 08/06/2019

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?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/08/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 44 YR
• Patient Weight: 127