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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APOLLO ORBERA INTRAGASTRIC BALLOON; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

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APOLLO ORBERA INTRAGASTRIC BALLOON; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY Back to Search Results
Lot Number S0003456
Device Problem Insufficient Information (3190)
Patient Problems Dehydration (1807); Nausea (1970); Vomiting (2144); Complaint, Ill-Defined (2331)
Event Date 08/14/2017
Event Type  Injury  
Event Description
I received the orbera balloon on (b)(6) 2017 after careful research and consultation with dr.(b)(6) and dr.(b)(6).I asked about statistics, etc, from everyone in the office and was assured that i would more than likely have some side effects of nausea but the new medication emend would take it away and this md even said that many of her patients feel well enough to go back to work the next day.Everyone was so upbeat about this balloon and my goal to rid myself of diabetes that i consented to the placement.However, after paying (b)(6) for the procedure out of pocket, i had the procedure under the "research" umbrella and was told that i would get (b)(6) back if i had the placement, etc.I understood this and again reiterated my main goal was to get rid of diabetes.However, my life almost ended after (b)(6) 2017.The first day of placement i was so medicated that i felt fair, however, the next several weeks left me clinging to life, literally.I was unable to drink, eat, hold anything down, repeatedly calling the office only to be told that this was "normal" - definitely what i'd been told all along.I became so week from dehydration that my husband had to carry me to the first appointment where i was begging to have the device removed and was told no by dr.(b)(6) because she was on call at another hospital and i would have to pay a lot of money if i took it out and she continued to refuse and tell me that i would just have to ride it out and she offered to give me an iv for (b)(6).I agreed to the iv because i was unable to stand up from weakness and then the nurse nor two other surgeons were able to give me an iv because i was so dehydrated and sick from this device placement.When the needles were being removed, there was not even a blood spot because i was so dry.They then told me that they could not stick me anymore because they had stuck me 4 times and told me to leave and go home and drink water.I explained that i couldn't drink because i kept vomiting and all three shrugged their shoulders.One of the surgeons said, "if this was my wife, this thing would definitely come out of her before she dies".The nurse left the room and then the business office ((b)(6)) came in to reprimand him and his comment and told him to leave.I then went home and back to bed and called the next day trying to schedule surgery, continuing to get pushed off until i told them that i would call the media and an attorney and it was finally scheduled for (b)(6) and was removed.In the surgery center, the staff told me that only one person has been able to leave this device in and that everyone has the same reaction to this device.I lost two weeks of work because of being unable to stand up, most importantly i almost lost my life at (b)(6).This device is unsafe and should not be permitted for use in any country on any human being.It's a deadly device and has no business being in the human body.Also, after having it removed i received a letter from the doctor dismissing me from her practice for my "noncompliance" with her weight management program.This is the biggest scam that i've ever seen or certainly experienced and i would appreciate an investigation to hopefully save someone else's life.As well, when i reported to the dr that the fda had recently released a report about this balloon she replied that the fda reports were "profanity" and that as a physician she has to report everything that happens against herself within 30 days whether or not she was the surgeon.I asked about the death of these people and she told me not to worry, i asked how could i not worry when i was having such bad side effects and she said i needed to stop getting myself "worked up".
 
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Brand Name
ORBERA INTRAGASTRIC BALLOON
Type of Device
IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Manufacturer (Section D)
APOLLO
MDR Report Key6830759
MDR Text Key84372895
Report NumberMW5071860
Device Sequence Number1
Product Code LTI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator No Information
Device Lot NumberS0003456
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/30/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
Patient Weight87
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