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 | 19039993 |
MDR Text Key | 339330210 |
Report Number | 3012638928-2024-03051 |
Device Sequence Number | 1 |
Product Code |
LTI
|
UDI-Device Identifier | 860005178810 |
UDI-Public | (01)860005178810(17)2025-04-10(10)230410 |
Combination Product (y/n) | N |
Reporter Country Code | CO |
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 |
Replace |
Type of Report
| Initial |
Report Date |
04/04/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | A-SP3-03K |
Device Lot Number | 230410 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/07/2024
|
Initial Date FDA Received | 04/04/2024 |
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 Number | 1 |
|
|