Brand Name | ARROW DRAINAGE SET |
Type of Device | CATHETER, IRRIGATION |
Manufacturer (Section D) |
ARROW INTERNATIONAL INC. |
reading PA |
|
Manufacturer (Section G) |
ARROW INTERNACIONAL DE CHIHUAHUA S.A. DE C.V |
ave. washington 3701, edificio 4 |
colonia complejo industrial, las americas |
chihuahua 31114 |
MX
31114
|
|
Manufacturer Contact |
katharine
tarpley
|
3015 carrington mill blvd |
morrisville, NC 27560
|
9194334854
|
|
MDR Report Key | 7309412 |
MDR Text Key | 101375655 |
Report Number | 3003737899-2018-00021 |
Device Sequence Number | 1 |
Product Code |
GBX
|
Combination Product (y/n) | N |
Reporter Country Code | SF |
PMA/PMN Number | K895516 |
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 |
Report Date |
02/20/2018 |
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 | 08/31/2022 |
Device Catalogue Number | AI-01600 |
Device Lot Number | 13F17J0155 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/28/2018 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/20/2018 |
Initial Date FDA Received | 03/02/2018 |
Supplement Dates Manufacturer Received | 04/09/2018
|
Supplement Dates FDA Received | 04/10/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 09/11/2017 |
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 | 65 YR |
|
|