Brand Name | G PROBE |
Type of Device | LASER INSTRUMENT, SURGICAL, POWERED, PRODUCT CODE: HQF |
Manufacturer (Section D) |
IRIDEX CORPORATION |
1212 terra bella ave. |
mountain view CA 94043 1824 |
|
Manufacturer (Section G) |
IRIDEX CORPORATION |
1212 terra bella ave |
|
mountain view CA 94043 9149 |
|
Manufacturer Contact |
madhumita
srikanth
|
1212 terra bella ave. |
mountain view, CA 94043-1824
|
6502189149
|
|
MDR Report Key | 16015628 |
MDR Text Key | 305816894 |
Report Number | 2939653-2022-00039 |
Device Sequence Number | 1 |
Product Code |
HQF
|
Combination Product (y/n) | Y |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
11/14/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/20/2022 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 15980 |
Is the Reporter a Health Professional? |
Yes
|
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 |
Patient Outcome(s) |
Other;
|