Type of Device | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE |
Manufacturer (Section D) |
|
Manufacturer (Section G) |
|
Manufacturer Contact |
christina
arnt
|
25212 w. illinois route 120 |
round lake, IL 60073
|
2242703198
|
|
MDR Report Key | 3987106 |
MDR Text Key | 4636387 |
Report Number | 1416980-2014-25590 |
Device Sequence Number | 1 |
Product Code |
KDJ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Consumer,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
07/14/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
07/14/2014
|
Initial Date FDA Received | 08/07/2014 |
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 |
Treatment | 2.5% DIANEAL PD2 AMBUFLEX,; 1.5% DIANEAL PD2 AMBUFLEX,; 2.5% DIANEAL PD2 ULTRABAG,; 1.5% DIANEAL PD2 ULTRABAG, |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 55 YR |
|
|