Brand Name | EXTENSION SET |
Type of Device | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY |
Manufacturer (Section D) |
BAXTER HEALTHCARE - MOUNTAIN HOME |
1900 n highway 201 |
mountain home AR 72653 |
|
Manufacturer (Section G) |
BAXTER HEALTHCARE - MOUNTAIN HOME |
1900 n highway 201 |
|
mountain home AR 72653 |
|
Manufacturer Contact |
kinga
almasan
|
25212 w. illinois route 120 |
round lake, IL 60073
|
2242702068
|
|
MDR Report Key | 5303557 |
MDR Text Key | 33670062 |
Report Number | 1416980-2015-44609 |
Device Sequence Number | 1 |
Product Code |
FKX
|
Combination Product (y/n) | N |
Reporter Country Code | UK |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
03/09/2016 |
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 |
Lay User/Patient
|
Device Catalogue Number | R5C4480 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
11/18/2015 |
Initial Date FDA Received | 12/16/2015 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 03/09/2016
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |
|
|