Brand Name | PRISMAFLEX HF1400 |
Type of Device | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM |
Manufacturer (Section D) |
GAMBRO INDUSTRIES |
7 avenue lionel terray |
meyzieu 69883 |
FR 69883 |
|
Manufacturer (Section G) |
GAMBRO INDUSTRIES |
7 avenue lionel terray |
|
meyzieu |
FR
|
|
Manufacturer Contact |
|
25212 w. illinois route 120 |
round lake, IL 60073
|
2242702068
|
|
MDR Report Key | 6755177 |
MDR Text Key | 81489415 |
Report Number | 8010182-2017-00052 |
Device Sequence Number | 1 |
Product Code |
KDI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K042938 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial |
Report Date |
07/31/2017 |
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 |
Health Professional
|
Device Expiration Date | 12/01/2018 |
Device Model Number | N/A |
Device Catalogue Number | 107142 |
Device Lot Number | 16L1503 |
Other Device ID Number | N/A |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 07/31/2017 |
Distributor Facility Aware Date | 07/05/2017 |
Device Age | 6 MO |
Event Location |
Hospital
|
Date Report to Manufacturer | 07/31/2017 |
Initial Date Manufacturer Received |
07/05/2017 |
Initial Date FDA Received | 07/31/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/01/2016 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|