Brand Name | ADMIRAL XTREME OTW |
Type of Device | CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL |
Manufacturer (Section D) |
MEDTRONIC MEXICO |
avenida paseo del cucapah #105 |
parque industrial el lago |
tijuana, b.c.,mx |
|
Manufacturer (Section G) |
MEDTRONIC IRELAND |
parkmore business park west |
|
galway |
|
Manufacturer Contact |
toni
o'doherty
|
parkmore business park west |
galway
|
091708734
|
|
MDR Report Key | 5297059 |
MDR Text Key | 34144975 |
Report Number | 9612164-2015-01873 |
Device Sequence Number | 1 |
Product Code |
LIT
|
Combination Product (y/n) | N |
Reporter Country Code | SZ |
PMA/PMN Number | K062809 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
12/01/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/15/2015 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 03/31/2018 |
Device Catalogue Number | SBI070040080 |
Device Lot Number | 209407009 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 12/01/2015 |
Date Device Manufactured | 03/31/2015 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Age | 00075 YR |
Patient Weight | 75 |
|
|