Brand Name | ACCESS |
Type of Device | SYSTEM, IRRIGATION, UROLOGICAL |
Manufacturer (Section D) |
BAXTER HEALTHCARE |
600 mts oeste de entrada |
cartago |
CS |
|
Manufacturer (Section G) |
BAXTER HEALTHCARE |
600 mts oeste de entrada |
|
cartago |
CS
|
|
Manufacturer Contact |
christina
arnt
|
25212 w. illinois route 120 |
round lake, IL 60073
|
2242703198
|
|
MDR Report Key | 4031188 |
MDR Text Key | 4804001 |
Report Number | 1416980-2014-27652 |
Device Sequence Number | 1 |
Product Code |
LJH
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K960787 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
07/29/2014 |
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 |
Other
|
Device Expiration Date | 01/27/2019 |
Device Catalogue Number | 2C4040 |
Device Lot Number | R14A27062 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/05/2014 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
11/17/2014
|
Initial Date FDA Received | 08/22/2014 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 12/11/2014
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/27/2014 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |