Brand Name | PANORAMIC X-RAY MODEL LASER-1000 |
Type of Device | PC-1000/LASER1000 |
Manufacturer (Section D) |
PANORAMIC CORP. |
fort wayne IN |
|
Manufacturer Contact |
|
4321 goshen rd. |
fort wayne, IN 46818
|
8006542027
|
|
MDR Report Key | 4881448 |
MDR Text Key | 6262677 |
Report Number | 1832462-2015-00059 |
Device Sequence Number | 1 |
Product Code |
EHD
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K882436 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Dentist
|
Remedial Action |
Repair |
Type of Report
| Initial |
Report Date |
06/20/2015 |
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 | 800724-3 |
Device Lot Number | 6000-13885 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
07/14/2004
|
Initial Date FDA Received | 06/25/2015 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 05/01/2002 |
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 |
Patient Outcome(s) |
Other;
|
|
|