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 | 16492612 |
MDR Text Key | 310770767 |
Report Number | 9615728-2023-00001 |
Device Sequence Number | 1 |
Product Code |
NAJ
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K021397 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Company Representative,Distributor |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
02/22/2023 |
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 Model Number | 00884450403204 |
Device Catalogue Number | S220GH |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/22/2023
|
Initial Date FDA Received | 03/06/2023 |
Supplement Dates Manufacturer Received | 03/09/2023
|
Supplement Dates FDA Received | 03/15/2023
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
Life Threatening;
|
|
|