Brand Name | HELIOS 3000 TRACK MOUNTED DENTAL LIGHT |
Type of Device | DENTAL LIGHT |
Manufacturer (Section D) |
PELTON & CRANE |
11727 fruehauf drive |
charlotte NC 28273 |
|
Manufacturer (Section G) |
PELTON & CRANE |
11727 fruehauf drive |
|
charlotte NC 28273 |
|
Manufacturer Contact |
frank
ray
|
11727 fruehauf drive |
charlotte, NC 28273
|
7045877227
|
|
MDR Report Key | 7235771 |
MDR Text Key | 99194215 |
Report Number | 1017522-2018-00003 |
Device Sequence Number | 1 |
Product Code |
EAZ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Dentist
|
Type of Report
| Initial |
Report Date |
01/11/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/02/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Dentist
|
Device Model Number | HL3T |
Device Catalogue Number | HL3T |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 01/11/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/19/2009 |
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 |