Brand Name | LARES RESEARCH |
Type of Device | HIGH-SPEED DENTAL HANDPIECE |
Manufacturer (Section D) |
LARES RESEARCH |
295 lockheed avenue |
chico CA 95973 |
|
Manufacturer (Section G) |
LARES RESEARCH |
295 lockheed avenue |
|
chico CA 95973 |
|
Manufacturer Contact |
bruce
holderbein
|
295 lockheed avenue |
chico, CA 95973
|
5303451767
|
|
MDR Report Key | 16993036 |
MDR Text Key | 316486405 |
Report Number | 2916440-2023-00009 |
Device Sequence Number | 1 |
Product Code |
EFB
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K141221 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Dentist
|
Remedial Action |
Replace |
Type of Report
| Initial |
Report Date |
05/24/2023 |
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 Model Number | 557 LEGACY 5 |
Device Catalogue Number | 13132-236 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/19/2023 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
05/15/2023
|
Initial Date FDA Received | 05/24/2023 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 04/30/2018 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |