Brand Name | SPRAY SET REGULATOR |
Type of Device | SYRINGE, PISTON |
Manufacturer (Section D) |
BAXTER HEALTHCARE CORPORATION |
deerfield IL |
|
Manufacturer (Section G) |
BAXTER HEALTHCARE - LESSINES |
boulevard rene branquart 80 |
|
lessines |
BE
|
|
Manufacturer Contact |
|
25212 w. illinois route 120 |
round lake, IL 60073
|
2242702068
|
|
MDR Report Key | 17134102 |
MDR Text Key | 317216633 |
Report Number | 1416980-2023-02921 |
Device Sequence Number | 1 |
Product Code |
FMF
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K050495 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Study,Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
07/19/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/15/2023 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | 1504719 |
Device Lot Number | E07767 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 07/18/2023 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | COSEAL SPRAY SET; COSEAL SURGICAL SEALANT |
Patient Outcome(s) |
Required Intervention;
|
Patient Sex | Male |
|
|