Brand Name | PRISMAFLEX SET |
Type of Device | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM |
Manufacturer (Section D) |
GAMBRO INDUSTRIES |
one baxter parkway |
deerfield IL 60015 |
|
MDR Report Key | 10704072 |
MDR Text Key | 212131058 |
Report Number | 10704072 |
Device Sequence Number | 1 |
Product Code |
KDI
|
UDI-Device Identifier | 07332414064556 |
UDI-Public | (01)07332414064556 |
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
09/28/2020,09/09/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/20/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Model Number | M100 |
Device Catalogue Number | 106697 |
Device Lot Number | 20E2203 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 09/28/2020 |
Device Age | 4 MO |
Event Location |
Hospital
|
Date Report to Manufacturer | 10/20/2020 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|