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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APOLLO ENDOSURGERY ORBERA GASTRIC BALLOON; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
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APOLLO ENDOSURGERY ORBERA GASTRIC BALLOON; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Dehydration (1807); Vomiting (2144); Burning Sensation (2146); Electrolyte Imbalance (2196); Shaking/Tremors (2515)
Event Date 06/02/2017
Event Type  Injury  
Event Description
I had the obera balloon on (b)(6) in the afternoon.By that night i was unable to keep anything down-severe vomiting although i had numerous medications ordered (and taken) to combat it.By saturday afternoon i felt as if my stomach was on fire.I had muscle tremors and the severe vomiting continued.Told my husband if i didn't get to an er i would die.I'm an rn.I knew i was in trouble.Admitted to hospital and placed on numerous iv drips for pain, vomiting, dehydration and very low potassium level.Doctor at my insistence removed the balloon on monday am.I have been left with a deep burning sensation in my stomach.Nothing helps.Worse experience of my life.Felt like my stomach was going to explode.Severe burning.I was unsure why this occurred.Still have the burning.
 
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Brand Name
ORBERA GASTRIC BALLOON
Type of Device
IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Manufacturer (Section D)
APOLLO ENDOSURGERY
MDR Report Key6794059
MDR Text Key82814016
Report NumberMW5071567
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 08/13/2017
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 Received08/13/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
Patient Weight95
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