Brand Name | FORZA F5 1:5 ATTACHMENT OPTIC |
Type of Device | HANDPIECE |
Manufacturer (Section D) |
NSK NAKANISHI INC |
700 shimohinata kanuma tochigi |
322-8 666 |
JA 322-8666 |
|
MDR Report Key | 16520439 |
MDR Text Key | 311039045 |
Report Number | 1032227-2023-00002 |
Device Sequence Number | 1 |
Product Code |
EGS
|
UDI-Device Identifier | 00887919660040 |
UDI-Public | (01)00887919660040 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Reporter Occupation |
Administrator/Supervisor
|
Type of Report
| Initial,Followup |
Report Date |
03/13/2023,03/10/2023 |
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
|
Device Operator |
Health Professional
|
Device Model Number | 5021285U0 |
Device Catalogue Number | 5021285U0 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/08/2023 |
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 03/13/2023 |
Distributor Facility Aware Date | 03/01/2023 |
Event Location |
Other
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 03/10/2023 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 03/13/2023
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 78 YR |
Patient Sex | Male |
Patient Weight | 79 KG |
|
|