MAUDE Adverse Event Report: GASTRIC LAP BAND

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problems Abdominal Pain (1685); Injury (2348)

Event Date 10/03/2013

Event Type  Injury  

Event Description

I had to have my gastric lap band removed after getting it fixed after it broke twice.The second time the hose wrapped around my spleen and damaged it.I continually have stomach and intestinal issues.The pain in my stomach is unbearable.I have severe spasms that come quite regular right where the port was located.The gastro doctor said there is no fix for this issue.It's debilitating and has almost made me to have to quit working.I am in a group with thousands of people who have been permanently damaged by the lap band.The care you receive when you have a lap band can be a nightmare.Many turned away from er because they cannot help them and refuse to touch a bariatric patient.This device is garbage.My doctor and many other doctors are now refusing to place them due to the many problems caused by the band.Yet the manufacturer is not held accountable.We want some help here.We are suffering and no one cares.(b)(6) has now started a class action suite.Why can't we?.

• Brand Name: GASTRIC LAP BAND
• Type of Device: GASTRIC LAP BAND
• MDR Report Key: 6940584
• MDR Text Key: 89254471
• Report Number: MW5072714
• 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: 10/06/2017

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: 10/11/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 57 YR
• Patient Weight: 88