Brand Name | SARA 3000 |
Type of Device | NONE |
Manufacturer (Section D) |
ARJOHUNTLEIGH POLSKA SP. ZO.O. |
ul. ks. wawrzyniaka 2 |
komorniki PL-6 2052 |
PL PL-62052 |
|
Manufacturer (Section G) |
ARJOHUNTLEIGH POLSKA SP. ZO.O. |
ul. ks. wawrzyniaka 2 |
|
komorniki PL-6 2052 |
PL
PL-62052
|
|
Manufacturer Contact |
pamela
wright
|
12625 wetmore |
ste 308 |
san antonio, TX 78247
|
2102787040
|
|
MDR Report Key | 3764657 |
MDR Text Key | 4470156 |
Report Number | 3007420694-2014-00045 |
Device Sequence Number | 1 |
Product Code |
FNG
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Company Representative |
Remedial Action |
Notification |
Type of Report
| Initial |
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? |
No
|
Device Operator |
Other
|
Initial Date Manufacturer Received |
04/01/2014 |
Initial Date FDA Received | 04/08/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/01/2004 |
Is the Device Single Use? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |