Brand Name | EMBOSPHERE® |
Type of Device | AGENTS, EMBOLIC, FOR TREATMENT OF UTERINE FIBROIDS |
Manufacturer (Section D) |
MERIT MEDICAL, INC - ROISSY |
bat. a- parc des nations |
383 rue de la belle etoile |
roissy charles de gaulle, cedex 95958 |
FR 95958 |
|
Manufacturer (Section G) |
MERIT MEDICAL, INC - ROISSY |
bat. a- parc des nations |
383 rue de la belle etoile |
roissy charles de gaulle, cedex 95958 |
FR
95958
|
|
Manufacturer Contact |
bryson
heaton
|
1600 merit parkway |
south jordan, UT 84095
|
8012084662
|
|
MDR Report Key | 18466527 |
MDR Text Key | 332332191 |
Report Number | 9615728-2024-00001 |
Device Sequence Number | 1 |
Product Code |
NAJ
|
UDI-Device Identifier | 00884450403402 |
UDI-Public | 00884450403402 |
Combination Product (y/n) | Y |
Reporter Country Code | CH |
PMA/PMN Number | K021397 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,User Facility,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup,Followup |
Report Date |
12/29/2023 |
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 Catalogue Number | S410GH/CNA |
Device Lot Number | X2588763_ |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
12/29/2023
|
Initial Date FDA Received | 01/08/2024 |
Supplement Dates Manufacturer Received | 01/19/2024 01/19/2024
|
Supplement Dates FDA Received | 01/24/2024 02/05/2024
|
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 02/02/2023 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Sex | Female |
|
|