Brand Name | CHLORAPREP UNKNOWN |
Type of Device | 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL |
Manufacturer (Section D) |
CAREFUSION 213, LLC 0113 |
1550 northwestern dr |
el paso TX 79912 |
|
Manufacturer (Section G) |
CAREFUSION, INC |
75 n. fairview drive |
|
vernon hills IL 60061 |
|
Manufacturer Contact |
anna
wehrheim
|
75 n. fairview drive |
vernon hills, IL 60061
|
8015652341
|
|
MDR Report Key | 11709745 |
MDR Text Key | 255400823 |
Report Number | 3004932373-2021-00212 |
Device Sequence Number | 1 |
Product Code |
KXF
|
Combination Product (y/n) | Y |
Reporter Country Code | UK |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,other |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
04/09/2021 |
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 |
Other
|
Device Catalogue Number | 270400 |
Device Lot Number | UNKNOWN |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/08/2021
|
Initial Date FDA Received | 04/22/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|