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 | 8915473 |
MDR Text Key | 155070516 |
Report Number | 9612164-2019-03509 |
Device Sequence Number | 1 |
Product Code |
LOX
|
UDI-Device Identifier | 00643169560024 |
UDI-Public | 00643169560024 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K143480 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Physician
|
Remedial Action |
Recall |
Type of Report
| Initial,Followup,Followup |
Report Date |
10/07/2019 |
1 Device 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 | 06/05/2021 |
Device Catalogue Number | EUP2515X |
Device Lot Number | 217850427 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 09/02/2019 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
08/19/2019 |
Initial Date FDA Received | 08/21/2019 |
Supplement Dates Manufacturer Received | 08/21/2019 09/12/2019
|
Supplement Dates FDA Received | 09/18/2019 10/07/2019
|
Date Device Manufactured | 06/06/2019 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | 9612164-09-12-2019-001-R |