Brand Name | AMPHIRION DEEP OTW |
Type of Device | CATHETER, PERCUTANEOUS |
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 | 5317577 |
MDR Text Key | 34756614 |
Report Number | 9612164-2015-01917 |
Device Sequence Number | 1 |
Product Code |
DQY
|
Combination Product (y/n) | N |
Reporter Country Code | SN |
PMA/PMN Number | K052791 |
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,Followup,Followup |
Report Date |
04/07/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/22/2015 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 04/30/2018 |
Device Catalogue Number | AMD253210152 |
Device Lot Number | 209532771 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/22/2015 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 04/07/2016 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 05/11/2015 |
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 | 00065 YR |
Patient Weight | 70 |
|
|