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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN / APOLLO ENDOSURGERY INC IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

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ALLERGAN / APOLLO ENDOSURGERY INC IMPLANT, INTRAGASTRIC FOR MORBID OBESITY Back to Search Results
Device Problem Defective Device (2588)
Patient Problems Abdominal Pain (1685); Autoimmune Disorder (1732); Congenital Defect/Deformity (1782); Fatigue (1849); Pain (1994); Vomiting (2144); Anxiety (2328); Arthralgia (2355)
Event Date 04/01/2013
Event Type  Injury  
Event Description
Hello, my name is (b)(6).I would like to sue and get a settlement from the lapband company who lied to the fda and healthier.I had the lapband on 2010 to 2013.I suffered too long and i had enough.I am a victim.In 2010 i was working for (b)(6) in (b)(6).I have decided to use the lapband to be healthier and lose weight as its company promoted to be "safe" while lying to the government fda approved.I was not aware the lapband was defaulted and it was leaking in my body.Also i experienced a lot of pain in my stomach and fatigues while working.In 2009 i learned that i have an autoimmune disorder called sjogren syndrome, ra, lupus and sle with chronic fatigue and chronic pain and chronic joint pain.This disease is constantly attacking my body and restless.There are days i cannot get out bed just to brush my teeth and there are days i can walk to my mail box.I also suffered from social anxiety because i was vomiting everywhere because the foods was making sick due to the lapband.It gotten to the point i was just eating soups so i won't cause no distress to the lapband.In (b)(6) 2010 i was cleared disable.I decided to move to (b)(6) to be safe and heal and be healthier and raise my children.In 2011 i learned i was pregnant with my son (b)(6).The guidelines was totally different from (b)(6) to (b)(6) nonetheless the doctor deflate it completely to have a normal pregnancy.However, in (b)(6) 2012 i delivered my son with an induced labor due to the lack of fluids in the placenta and my beautiful boy was born with clubbed feet and hands bilaterally.It was a horrible and traumatic experiences.I had to help my son with pt, ot, speech dues to his autism to this day.Then in 2013 i learn i was pregnant but i had to go to the doctor in (b)(6) because i was having very sharp pains in my stomach like if i was stabbed by knives.Soon i learn the pregnancy i was very early (5-6 week), and had test to confirm if the lapband did move.And it was ripped from my stomach stitches.I had an emergency pregnancy while being is horrific pain, while pregnant and horrified.Luckily, (b)(6) hospital saved my life and most importantly my son (b)(6).In 2015 i had the gastric bypass surgery.The lapband company need to pay for my sufferings and the psychological inflicted and bodily injuries i have acquired.I enjoyed working and be independent and be able to provide for my family.I am permanently disabled while raising my disable children who will need more assistance due to autism.I tried contacting a lawyer but once i tell my history they always say we will call you back or call the bar association.I need a government lawyer.You can access my records for further studies and to pursuit in a class action lawsuit against this company that lied to federal government and made the public lose trust in my government.I collect (b)(6) and because my income is limited my resources are limited.You can review all my medical and insurance records for the case.I dont think it's fair for people like me to suffer only because the company was selfish and profit only and disregard to human valuable life.I am valuable and important to this society especially a natural born american women.So, please, i need help.Also lapband made billions of dollars from 2/2008 to 2013 while i was suffering with lapband in my body.Keep in mind i also suffer from ptsd due to childhood rape, (b)(6) i was raped again and filed a report in 2002 in (b)(6).I think i have suffered enough.The lapband must settle for my sufferings.I am demanding (b)(6) of dollars after all fees are payed to a good lawyer appointed by my judge.My insurance was (b)(6) in 2008 to 2009 i was with (b)(6) in 2010 and i think in 2012 i started having (b)(6).In (b)(6) and (b)(6).In 2016 i moved to (b)(6) so the insurance its different i have (b)(6) today.Dates are in mrn 2008- 2021.Allergan agrees to settlement in alleged defective lap-band case the one who lied to the fda.Allergan? it's in my "mrn".It's alot you can see it in my (b)(6) insurance.Fda safety report id# (b)(4).
 
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Brand Name
IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Type of Device
IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Manufacturer (Section D)
ALLERGAN / APOLLO ENDOSURGERY INC
MDR Report Key12086388
MDR Text Key259006907
Report NumberMW5102181
Device Sequence Number1
Product Code LTI
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/25/2021
2 Devices were Involved in the Event: 1   2  
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? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/29/2021
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Treatment
NONE FOR NOW JUST VITAMINS,
Patient Outcome(s) Congenital Anomaly; Hospitalization; Life Threatening; Disability;
Patient Age32 YR
Patient Weight107
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