MAUDE Adverse Event Report: SPATZ FGIA INC. SPATZ3 ADJUSTABLE BALLOON SYSTEM; GASTRIC BALLOON

Model Number A-SP3-03K

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

Patient Problem Coma (2417)

Event Type  Injury  

Event Description

The patient got into coma after the sedation.Update received saying that the balloon was removed, and that the patient was moved to another hospital.

• Brand Name: SPATZ3 ADJUSTABLE BALLOON SYSTEM
• Type of Device: GASTRIC BALLOON
• Manufacturer (Section D): SPATZ FGIA INC.; 1801 s perimeter rd, ste 130; fort lauderdale FL 33309
• Manufacturer (Section G): SPATZ FGIA INC.; 1801 s perimeter rd, ste 130; fort lauderdale FL 33309
• Manufacturer Contact: pnina polishuk ; 1801 s perimeter rd, ste 130; fort lauderdale, FL 33309
• MDR Report Key: 17601420
• MDR Text Key: 321713078
• Report Number: 3012638928-2023-02887
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: P190012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 08/23/2023

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: A-SP3-03K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/24/2023
• Initial Date FDA Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 72 YR
• Patient Sex: Female