Brand Name | 16FR SALEM W/ GIENTRI PORT WIT |
Type of Device | GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS |
Manufacturer (Section D) |
COVIDIEN |
calle 9 sur no. 125 cuidad ind |
tijuana 22500 |
MX 22500 |
|
Manufacturer (Section G) |
COVIDIEN |
calle 9 sur no. 125 cuidad ind |
|
tijuana 22500 |
MX
22500
|
|
Manufacturer Contact |
jill
saraiva
|
15 hampshire street |
mansfield, MA 02048
|
5084524970
|
|
MDR Report Key | 8549186 |
MDR Text Key | 143559349 |
Report Number | 9612030-2019-02159 |
Device Sequence Number | 1 |
Product Code |
PIF
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,user f |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
04/25/2019 |
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 |
No Information
|
Device Model Number | 7771610E |
Device Catalogue Number | 7771610E |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
04/16/2019
|
Initial Date FDA Received | 04/25/2019 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |