Brand Name | PLEURXTM PERITONEAL CATHETER SYSTEM |
Type of Device | PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING |
Manufacturer (Section D) |
CAREFUSION, INC |
400 east foster rd |
mannford OK 74044 |
|
Manufacturer (Section G) |
CAREFUSION, INC |
400 east foster rd |
|
mannford OK 74044 |
|
Manufacturer Contact |
anna
wehrheim
|
75 n. fairview drive |
vernon hills, IL 60061
|
8015652341
|
|
MDR Report Key | 13257568 |
MDR Text Key | 283815000 |
Report Number | 1625685-2022-00012 |
Device Sequence Number | 1 |
Product Code |
PNG
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | NA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Health Professional |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
01/06/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/14/2022 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | PMCF SURVEY |
Device Lot Number | UNKNOWN |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 12/20/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|