MAUDE Adverse Event Report: APOLLO ENDOSURGERY COSTA RICA S.R.L. ORBERA; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

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

Patient Problems Cardiac Arrest (1762); Hemorrhage/Bleeding (1888); Nausea (1970); Dizziness (2194)

Event Date 11/09/2021

Event Type  Injury  

Event Description

I had an orbera balloon placed on (b)(6) 2021, at (b)(6).On (b)(6), i went to the emergency room via ambulance in (b)(6) because i could not sit up or stand due to lightheadedness and nausea.Admitted to icu for 5 days for severe gi bleed, hemorrhagic shock, received 13 units of bloods, coded 3x, intubated, central line, norepinephrine, etc.After two egds, the bleeding was finally stopped with additional treatment and 3 clips.Also received fresh frozen plasma, platelets, and other iv meds/treatments.The balloon was removed during the first egd on (b)(6) 2021.Will send full hospitalization record via mail or email/upload.Fda safety report id# (b)(4).

• Brand Name: ORBERA
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): APOLLO ENDOSURGERY COSTA RICA S.R.L.
• MDR Report Key: 13093790
• MDR Text Key: 282956102
• Report Number: MW5106299
• 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: 12/23/2021

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?: Yes
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/27/2021
• Patient Sequence Number: 1
• Treatment: ARMOUR THYROID; DOTERRA LIFELONG VITALITY SUPPLEMENTS; HYDROCHLOROTHIAZIDE; PANTOPRAZOLE ; TYLENOL
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White