Brand Name | CUROS |
Type of Device | PAD, ALCOHOL, DEVICE DISINFECTANT |
Manufacturer (Section D) |
3M COMPANY |
3m center, 2510 conway ave. |
bldg. 275-5w-06 |
saint paul MN 55144 |
|
MDR Report Key | 6493194 |
MDR Text Key | 72806843 |
Report Number | 6493194 |
Device Sequence Number | 1 |
Product Code |
LKB
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
03/17/2017 |
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 |
Nurse
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 03/17/2017 |
Device Age | 4 DY |
Event Location |
Hospital
|
Date Report to Manufacturer | 03/17/2017 |
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 04/14/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Treatment | CUROS TIP BEING USED ON PRIMARY PLUM SET TUBING |
|
|