MAUDE Adverse Event Report: PANORAMIC CORP. PANORAMIC X-RAY MODEL PC-1000

Model Number 800724-1

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2015

Event Type  Injury  

Event Description

Machine was in use and fell all the way down.Patient was in te machine but not injured.

• Brand Name: PANORAMIC X-RAY MODEL 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: 5327024
• MDR Text Key: 34418816
• Report Number: 1832462-2015-00072
• 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: health professional
• Reporter Occupation: Dentist
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 12/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 800724-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2008
• 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