MAUDE Adverse Event Report: ETHICON ENDO-SURGERY / JOHNSON & JOHNSON REALIZE LAP BAND

Model Number Y7M2Y3L3K9L2W7R6

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

Patient Problems Gastritis (1874); Pain (1994); Discomfort (2330); Injury (2348); Choking (2464)

Event Type  Injury  

Event Description

I had a realize lap band put in, in 2009.I soon had problems eating the way they told me.I wanted it out but was told insurance wouldn't take it out.I had horrible gerd- pain when eating and choking at night on fluid.In 2015 i tried to get it removed but was denied.Finally in (b)(6) 2018 after my stomach was rotated and years of horrible gerd, i got it removed.I am having a scope (b)(6) 2018 to see what long term damage it caused.It was the worst mistake of my life getting it.You can't eat vegetables- lettuce-or proteins unless you lube them with mayo.It¿s not a weight loss tool at all.It does nothing but give you gerd and damage your esophagus, i also had ongoing discomfort at port site.It should be removed from the market.

• Brand Name: REALIZE LAP BAND
• Type of Device: REALIZE LAP BAND
• Manufacturer (Section D): ETHICON ENDO-SURGERY / JOHNSON & JOHNSON
• MDR Report Key: 7925878
• MDR Text Key: 122477206
• Report Number: MW5080240
• 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: 09/28/2018

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
• Device Model Number: Y7M2Y3L3K9L2W7R6
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 111