Brand Name | PANORAMIC X-RAY MODEL PC-1000 |
Type of Device | PC-1000 |
Manufacturer (Section D) |
PANORAMIC CORP. |
4321 goshen rd. |
fort wayne IN 46818 |
|
Manufacturer (Section G) |
PANORAMIC CORP. |
4321 goshen rd. |
|
fort wayne IN 46818 |
|
Manufacturer Contact |
david
woods
|
4321 goshen rd. |
fort wayne, IN 46818
|
8006542027
|
|
MDR Report Key | 5249540 |
MDR Text Key | 32262247 |
Report Number | 1832462-2015-00066 |
Device Sequence Number | 1 |
Product Code |
EHD
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K870236 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
other |
Reporter Occupation |
Service Personnel
|
Remedial Action |
Repair |
Type of Report
| Initial |
Report Date |
10/20/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/20/2015 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Model Number | 800724-1 |
Device Lot Number | 6000-13885 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 10/20/2015 |
Was Device Evaluated by Manufacturer? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|