Brand Name | TRULIGHT |
Type of Device | TRULIGHT 5000 / 3000 DUO |
Manufacturer (Section D) |
TRUMPF MEDIZIN SYSTEME GMBH + CO. KG |
carl-zeiss strasse 7-9 |
saalfeld, 07318 |
GM 07318 |
|
Manufacturer Contact |
steffen
ulbrich
|
carl-zeiss strasse 7-9 |
saalfeld, 07318
|
GM
07318
|
|
MDR Report Key | 7469384 |
MDR Text Key | 107318417 |
Report Number | 9681407-2018-00020 |
Device Sequence Number | 1 |
Product Code |
FSY
|
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K102758 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign |
Reporter Occupation |
Service Personnel
|
Remedial Action |
Repair |
Type of Report
| Initial |
Report Date |
03/29/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/27/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 4038210 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 03/29/2018 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/21/2017 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|