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U.S. Department of Health and Human Services

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

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SPATZ FGIA INC. SPATZ3 ADJUSTABLE BALLOON SYSTEM; GASTRIC BALLOON Back to Search Results
Model Number A-SP3-03K
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Abdominal Pain (1685); Stomach Ulceration (4488)
Event Date 11/12/2022
Event Type  Injury  
Event Description
The doctor reports that the patient presented abdominal pain on the third day of implantation and proceeded to perform endoscopy and detected that the valve was stuck in the walls of the stomach causing an ulcer and on the fourth day he proceeded to remove the balloon.
 
Manufacturer Narrative
"to date, spatz fgia inc.Has not received the product for evaluation, therefore no analysis or testing has been done.A review of the device labeling notes the following: each patient must be monitored closely during the entire term of treatment in order to detect the development of possible complications.Each patient should be instructed to report to physicians immediately regarding any and all change of symptoms.Symptoms of deflation, gastrointestinal obstruction, ulceration and other complications which might occur should be reviewed with patient, and patients should be advised to contact his/her physician immediately upon the onset of such symptoms.If it is necessary to replace a balloon which has spontaneously deflated, the recommended initial fill volume of the replacement balloon is the same as for the first balloon or the most recent volume of the removed balloon.A greater initial fill volume in the replacement balloon may result in severe nausea, vomiting or ulcer formation.Injury to the lining of the digestive tract as a result of direct contact with the balloon, catheter, polypectomy snare, or as a result of increased acid production by the stomach - esophagitis, gastritis or duodenitis.This could lead to ulcer formation with pain, bleeding or even perforation.Surgery could be necessary to correct this condition, and could result in death.Spontaneous hyperinflation is the enlargement of the balloon with extra air that can occur spontaneously.This can lead to symptoms such as pain, nausea, vomiting, dehydration, ulceration, perforation, and could require a down adjustment or removal of the balloon.".
 
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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 Key16001465
MDR Text Key305682939
Report Number3012638928-2022-02749
Device Sequence Number1
Product Code LTI
Combination Product (y/n)N
Reporter Country CodeDR
PMA/PMN Number
P190012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 12/18/2022
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 NumberA-SP3-03K
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/28/2022
Initial Date FDA Received12/18/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age31 YR
Patient SexMale
Patient Weight107 KG
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