Brand Name | TOOMEY IRRIGATION SYRINGE |
Manufacturer (Section D) |
PRODUCTOS PARA EL CUIDADO DE LA SALUD |
nogales, sonora |
MX |
|
Manufacturer (Section G) |
PRODUCTOS PARA EL CUIDADO DE LA SALUD |
km. 7 carretera internacional |
|
nogales, sonora 8562 1 |
MX
85621
|
|
Manufacturer Contact |
christy
lewis
|
8195 industrial blvd. |
covington, GA 30014
|
7707846100
|
|
MDR Report Key | 4627887 |
MDR Text Key | 5588020 |
Report Number | 1018233-2015-00083 |
Device Sequence Number | 1 |
Product Code |
KYZ
|
Combination Product (y/n) | N |
Reporter Country Code | AS |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
02/24/2015 |
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 |
Health Professional
|
Device Catalogue Number | 0038460 |
Device Lot Number | NGYF0741 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/24/2015
|
Initial Date FDA Received | 03/19/2015 |
Was Device Evaluated by Manufacturer? |
No
|
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 |
|
|