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

Model Number 800724-1

Device Problem Component Falling (1105)

Patient Problems Contusion (1787); Laceration(s) (1946)

Event Date 10/07/2004

Event Type  Injury  

Event Description

A recall for this was initiated on (b)(6) 2015.Dr's office had a fire.Dr.Attempted to take an x-ray on himself to verify that the machine still was operational after the fire.The machine fell and cut the dr's ear and bruised his shoulder.

Manufacturer Narrative

No further information on the dr.

• 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: 4881472
• MDR Text Key: 5862434
• Report Number: 1832462-2015-00030
• 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: 06/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2015
• 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
• Date Manufacturer Received: 10/07/2004
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/1997
• 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