Brand Name | HENRY SCHEIN |
Type of Device | HANDPIECE |
Manufacturer (Section D) |
TTBIO CORP |
2f, no. 7, 6th road |
industry pa |
taichung, 40755 |
TW 40755 |
|
MDR Report Key | 18903740 |
MDR Text Key | 337662285 |
Report Number | 3007007357-2024-00006 |
Device Sequence Number | 1 |
Product Code |
EFB
|
UDI-Device Identifier | 00304040133682 |
UDI-Public | (01)00304040133682 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial,Followup |
Report Date |
03/22/2024 |
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
|
Device Operator |
Health Professional
|
Device Model Number | MAXIMA PRO 2L AR |
Device Catalogue Number | 570-2094 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 03/22/2024 |
Distributor Facility Aware Date | 02/15/2024 |
Device Age | 14 MO |
Event Location |
Outpatient Treatment Facility
|
Date Report to Manufacturer | 03/25/2024 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 03/14/2024 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 03/26/2024
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 75 YR |
Patient Sex | Male |
|
|