Brand Name | MINICAP |
Type of Device | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY |
Manufacturer (Section D) |
BAXTER HEALTHCARE - GUANGZHOU |
jiao yuan road, dong ji indust |
guangzhou 51073 0 |
CH 510730 |
|
Manufacturer (Section G) |
BAXTER HEALTHCARE - GUANGZHOU |
jiao yuan road, dong ji indust |
|
guangzhou 51073 0 |
CH
510730
|
|
Manufacturer Contact |
kinga
almasan
|
25212 w. illinois route 120 |
round lake, IL 60073
|
2242702068
|
|
MDR Report Key | 5484066 |
MDR Text Key | 39800204 |
Report Number | 1416980-2016-04659 |
Device Sequence Number | 1 |
Product Code |
FKX
|
Combination Product (y/n) | N |
Reporter Country Code | CH |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,distri |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
04/05/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/07/2016 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Expiration Date | 04/30/2017 |
Device Catalogue Number | 6AC4466 |
Device Lot Number | GM1506104 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/18/2016 |
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 03/25/2016 |
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 |
|
|