Brand Name | SPATZ3 ADJUSTABLE BALLOON SYSTEM |
Type of Device | GASTRIC BALLOON |
Manufacturer (Section D) |
SPATZ FGIA INC. |
1801 s perimeter rd, suite 130 |
fort lauderdale |
florida FL 33309 |
|
Manufacturer (Section G) |
SPATZ FGIA INC. |
1801 s perimeter rd, suite 130 |
fort lauderdale |
florida FL 33309 |
|
MDR Report Key | 15938082 |
MDR Text Key | 305043566 |
Report Number | 3012638928-2022-02514 |
Device Sequence Number | 1 |
Product Code |
LTI
|
Combination Product (y/n) | N |
Reporter Country Code | SA |
PMA/PMN Number | P190012 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional |
Reporter Occupation |
Physician
|
Remedial Action |
Other |
Type of Report
| Initial |
Report Date |
08/12/2022 |
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 Number | A-SP3-03S |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/07/2022
|
Initial Date FDA Received | 12/08/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
|
Patient Age | 23 YR |
Patient Sex | Female |
|
|