MAUDE Adverse Event Report: PANORAMIC CORPORATION PANORAMIC X-RAY MODEL LASER 1000; PC-1000/LASER 1000

Model Number 800724-3

Device Problem Component Falling (1105)

Patient Problem Injury (2348)

Event Date 01/28/2016

Event Type  Injury  

Event Description

The forehead support fell off the machine and hit a patient's nose which caused a cut.The office manager stated that the patient was fine.

• Brand Name: PANORAMIC X-RAY MODEL LASER 1000
• Type of Device: PC-1000/LASER 1000
• Manufacturer (Section D): PANORAMIC CORPORATION; 4321 goshen road; fort wayne IN 46818
• Manufacturer (Section G): PANORAMIC CORPORATION; 4321 goshen road; fort wayne IN 46818
• Manufacturer Contact: stephen yaggy ; 4321 goshen road; fort wayne, IN 46818 ; 8006542027
• MDR Report Key: 5442168
• MDR Text Key: 38382947
• Report Number: 1832462-2016-00001
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K882436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 02/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dental Assistant
• Device Model Number: 800724-3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/1997
• 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