Brand Name | BALLOON SLG 14FR X 2.0CM |
Type of Device | TUBES, GASTROINTESTINAL (AND ACCESSORIES) |
Manufacturer (Section D) |
CARDINAL HEALTH |
777 west street, mansfield, ma |
mansfield MA 02048 |
|
Manufacturer (Section G) |
CARDINAL HEALTH |
calle 9 sur no. 125 cuidad ind |
|
tijuana 22500 |
MX
22500
|
|
Manufacturer Contact |
jill
saraiva
|
777 west street |
mansfield, MA 02048
|
5086183640
|
|
MDR Report Key | 18124679 |
MDR Text Key | 328638429 |
Report Number | 9612030-2023-03858 |
Device Sequence Number | 1 |
Product Code |
KNT
|
Combination Product (y/n) | N |
Reporter Country Code | AS |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,User Facility,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup,Followup,Followup |
Report Date |
04/08/2024 |
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 Model Number | 714200 |
Device Catalogue Number | 714200 |
Device Lot Number | 2125709164 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
10/17/2023
|
Initial Date FDA Received | 11/13/2023 |
Supplement Dates Manufacturer Received | 10/17/2023 10/17/2023 10/17/2023
|
Supplement Dates FDA Received | 03/18/2024 03/18/2024 04/08/2024
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |