Brand Name | ENDOSEQUENCE |
Type of Device | ENDODONTIC FILE |
Manufacturer (Section D) |
FKG DENTAIRE SA |
cret-du-locle 4 |
la chaux-de-fonds, CH230 0 |
SZ CH2300 |
|
MDR Report Key | 6818893 |
MDR Text Key | 83606860 |
Report Number | 1032227-2017-00002 |
Device Sequence Number | 1 |
Product Code |
EKS
|
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 |
08/24/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/24/2017 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Dentist
|
Device Model Number | SEQ MED RF 04 25 ASST |
Device Catalogue Number | 5009013U0 |
Device Lot Number | 34678 |
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 | 08/24/2017 |
Distributor Facility Aware Date | 07/24/2017 |
Event Location |
Other
|
Date Report to Manufacturer | 08/24/2017 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 24 YR |
Patient Weight | 57 |
|
|