Brand Name | PUDENDAL BLOCK TRAY |
Type of Device | SET, ANESTHESIA, PARACERVICAL |
Manufacturer (Section D) |
CAREFUSION 2200, INC. |
400 east foster rd. |
mannford OK 74044 |
|
MDR Report Key | 6653064 |
MDR Text Key | 77939609 |
Report Number | 6653064 |
Device Sequence Number | 1 |
Product Code |
HEE
|
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 |
Patient
|
Type of Report
| Initial |
Report Date |
06/07/2017,06/12/2017 |
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 |
Physician
|
Device Expiration Date | 04/28/2020 |
Device Model Number | 4541 |
Device Catalogue Number | 4541 |
Device Lot Number | 0000800489 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 06/07/2017 |
Device Age | 0 YR |
Event Location |
Hospital
|
Date Report to Manufacturer | 06/07/2017 |
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 06/20/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|