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

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Hemorrhage/Bleeding (1888); Nausea (1970); Shock (2072); Dizziness (2194)

Event Date 11/09/2021

Event Type  Injury  

Event Description

I received orbera balloon on (b)(6) 2021, at (b)(6).On (b)(6) 2021 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 icu for severe gi bleed, hemorrhagic shock, received 13 units of bloods, coded 3x, intubated, etc.

• Brand Name: ORBERA ENDOSCOPY / ORBERA
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): APOLLO ENDOSURGERY COSTA RICA S.R.L.
• MDR Report Key: 13634663
• MDR Text Key: 286494338
• Report Number: MW5107793
• 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: 12/22/2021

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?: No
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/28/2022
• Patient Sequence Number: 1
• Treatment: "DO TERRA" LIFELONG VITALITY SUPPLEMENTS; ARMOUR THYROID; BREAST IMPLANTS; HYDROCHLOROTHIAZIDE ; IUD; PANTOPRAZOLE; TYLENOL
• Patient Outcome(s): Hospitalization; Disability; Required Intervention; Life Threatening
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White