MAUDE Adverse Event Report: SPATZ FGIA INC. SPATZ 3 ADJUSTABLE BALLOON SYSTEM INSERTION KIT; GASTRIC BALLOON SYSTEM

Model Number SPATZ ADJUSTABLE BALLOON SYSTEM

Device Problem Product Quality Problem (1506)

Patient Problems Abdominal Pain (1685); Irritation (1941); Internal Organ Perforation (1987)

Event Date 08/25/2016

Event Type  Injury  

Event Description

Respected sir, sub: danger to the life of (b)(6) public by sale of instruments, equipments and other items by foreign companies in (b)(6) without approval from (b)(6) govt.I wish to inform you that the following company is selling spatz3 adjustable balloon system insertion kit in rs.One lacs to (b)(6) hospital.(b)(6).They are selling the above kit through their (b)(6) representative - (b)(6).In fact, they are the greatest cheaters.My life was put to a great danger by their kit.The details are given as under: - as i was overweight, i had undergone endoscopic insertion of bariatric balloon - spatz3 adjustable balloon system insertion kit on (b)(6) 2016.I had paid medical bill of (b)(6) amounting to (b)(6) in which they charged (b)(6) for this kit.After insertion of the balloon, on (b)(6) 2016, i started feeling pain in abdomen.The balloon was giving continuously irritation and pain.On (b)(6) 2016, the pain became unbearable.I rushed to (b)(6) and reached to (b)(6), where immediately, x ray and ct scan abdomen was done which diagnosed peptic perforation.The endoscopic surgeon had done emergency endoscopy to remove the bariatric balloon and the surgeon had done laparotomy for repair of the perforation.I am thankful to the team of doctors whose untiring efforts have given me a new life.The amount paid by me for the medical bill to (b)(6) on (b)(6) 2016 was (b)(6) including the cost of balloon amounting to (b)(6).Subsequently, after this crisis is over for the period of (b)(6) 2016, at the time of discharge, i have paid (b)(6) as medical bill to (b)(6).These bills apart from many other expenses incurred by me totally are more than (b)(6).The medical insurance company (b)(6) insurance company and the third party administrator - (b)(6) has not reimbursed to me any amount, although i have been insured for a sum of (b)(6) by (b)(6) as retired officer.On writing to mr.(b)(6), managing director of (b)(4), he has informed that it is a common thing and they are not responsible for such casualty.They have also refused to give any compensation for the expenses incurred by me in saving my life.Thus, this company is earning from the patients of our country but are not taking any responsibility.I trust you will take up this matter with appropriate authority and arrange to give relief to indian public.Yours truly, (b)(6).I was operated in (b)(6) for saving my life.I enclose herewith the discharge summary as an attachment.

• Brand Name: SPATZ 3 ADJUSTABLE BALLOON SYSTEM INSERTION KIT
• Type of Device: GASTRIC BALLOON SYSTEM
• Manufacturer (Section D): SPATZ FGIA INC. ; 15 cuttermill rd. ; great neck NY 11021
• MDR Report Key: 6431408
• MDR Text Key: 70911806
• Report Number: MW5068634
• Device Sequence Number: 1
• Product Code: LTI
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/22/2017

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: Health Professional
• Device Model Number: SPATZ ADJUSTABLE BALLOON SYSTEM
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/22/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OTC MEDS: NIL; RX MEDS: NIL
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 105