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

Model Number 800724-1

Device Problems Component Falling (1105); Nonstandard Device (1420)

Patient Problems Head Injury (1879); Pain (1994); Numbness (2415)

Event Date 01/23/2008

Event Type  Injury  

Event Description

A recall for this issue was initiated on 04/23/2015.Machine fell and struck a pt in the head.As a result, the pt had headaches, dizziness, weakness and numbness on left side, numbness of index and middle fingers on left hand, and extreme pain and suffering and mental anguish and distress.No further info on the pt.

• Brand Name: PANORAMIC X-RAY MODEL PC-1000
• Type of Device: PC-1000
• Manufacturer (Section D): PANORAMIC CORP.; fort wayne IN
• Manufacturer Contact: 4321 goshen rd.; fort wayne, IN 46818 ; 8006542027
• MDR Report Key: 4881490
• MDR Text Key: 17584208
• Report Number: 1832462-2015-00047
• 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: 06/18/2015

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: 800724-1
• Device Lot Number: 6000 - 13885
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2008
• Initial Date FDA Received: 06/25/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2001
• 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