Brand Name | PROTECTIV PLUS |
Type of Device | CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS |
Manufacturer (Section D) |
SMITHS MEDICAL ASD, INC. |
10 bowman dr. |
keene, NH 03431 |
|
MDR Report Key | 5476040 |
MDR Text Key | 39530900 |
Report Number | 5476040 |
Device Sequence Number | 1 |
Product Code |
FOZ
|
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 |
01/29/2016,02/01/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Device Operator |
Nurse
|
Device Expiration Date | 06/01/2018 |
Device Lot Number | ST2993704 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 01/29/2016 |
Event Location |
Hospital
|
Date Report to Manufacturer | 01/29/2016 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 03/03/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 1 YR |
|
|