Brand Name | OPUS COLIBIRI |
Type of Device | OPUS COLIBRI |
Manufacturer (Section D) |
ALMA LASERS LTD |
18 haharash street |
north industrial park |
caesarea, 30798 95 |
IS 3079895 |
|
MDR Report Key | 18552406 |
MDR Text Key | 333359404 |
Report Number | 3004450661-2024-00002 |
Device Sequence Number | 1 |
Product Code |
GEI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Reporter Occupation |
Dentist
|
Type of Report
| Initial |
Report Date |
01/22/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 01/22/2024 |
Distributor Facility Aware Date | 01/01/2024 |
Event Location |
Outpatient Treatment Facility
|
Date Report to Manufacturer | 01/22/2024 |
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 01/22/2024 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Sex | Male |
|
|