Brand Name | EUPHORA RX |
Type of Device | CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS |
Manufacturer (Section D) |
MEDTRONIC MEXICO |
av. paseo del cucapah #10510 |
tijuana,bc 22570 |
MX 22570 |
|
Manufacturer (Section G) |
MEDTRONIC MEXICO |
av. paseo del cucapah #10510 |
|
tijuana,bc 22570 |
MX
22570
|
|
Manufacturer Contact |
toni
o'doherty
|
parkmore business park west |
galway
|
091708734
|
|
MDR Report Key | 6803074 |
MDR Text Key | 83116729 |
Report Number | 9612164-2017-01131 |
Device Sequence Number | 1 |
Product Code |
LOX
|
Combination Product (y/n) | N |
Reporter Country Code | AS |
PMA/PMN Number | K143480 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Remedial Action |
Recall |
Type of Report
| Initial,Followup |
Report Date |
10/18/2017 |
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 Expiration Date | 02/17/2019 |
Device Catalogue Number | EUP27512X |
Device Lot Number | 212820596 |
Was Device Available for Evaluation? |
Yes
|
Date Returned to Manufacturer | 08/10/2017 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
07/20/2017 |
Initial Date FDA Received | 08/18/2017 |
Supplement Dates Manufacturer Received | 09/20/2017
|
Supplement Dates FDA Received | 10/18/2017
|
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 02/21/2017 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | Z-3136-2017 |
Patient Sequence Number | 1 |
|
|