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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

I am physician and undergone an intra gastric balloon placement in (b)(6) 2022.Few month after placement i felt hard bulging area in my abdomen.I was told it is balloon that turned palpable after losing some weight.After balloon removal in (b)(6) 2022.The mass was there and after study it was diagnosed malignant sarcoma.Now this sarcoma metastasized to my lungs and abdomen.I underwent surgery in (b)(6) 2022 and i am receiving chemo.The instruction for product not recommending any imaging before or during placement which can mask intra abdominal tumor.In my case if this tumor diagnosed earlier i had a better chance to fight it.This product really took away my chance to timely diagnosis of my intra abdominal tumor and significantly deteriorated my prognosis.My name is (b)(6) and my cell is (b)(6).My medical record is available as per request.Best regards.

• Brand Name: ORBERA INTRA GASTRIC BALLOON
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): APOLLO ENDOSURGERY COSTA RICA S.R.L.
• MDR Report Key: 16312947
• MDR Text Key: 309052609
• Report Number: MW5114745
• 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: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization; Disability; Other; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 107 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White