Brand Name | FLUENT CONSOLE |
Type of Device | INSUFFLATOR, HYSTEROSCOPIC |
Manufacturer (Section D) |
HOLOGIC, INC. |
250 campus drive |
marlborough, MA 01752 |
|
Manufacturer (Section G) |
HOLOGIC, INC. |
250 campus drive |
|
marlborough, MA 01752 |
|
Manufacturer Contact |
daniel
guevara
|
562 parkway |
coyol free zone building b24 |
san jos[?], alajuela 20102- CRI
|
CS
20102 CRI
|
|
MDR Report Key | 14175685 |
MDR Text Key | 289906695 |
Report Number | 1222780-2021-00031 |
Device Sequence Number | 1 |
Product Code |
HIG
|
UDI-Device Identifier | 15420045508552 |
UDI-Public | (01)15420045508552 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K180825 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
04/21/2022 |
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 | FLT-100 |
Device Catalogue Number | FLT-100 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/16/2021
|
Initial Date FDA Received | 04/21/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/24/2020 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
Hospitalization;
|
Patient Sex | Female |
|
|