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

Model Number 800724-1

Device Problems Unintended Collision (1429); Device Slipped (1584)

Patient Problem Pain (1994)

Event Date 06/06/2013

Event Type  Injury  

Event Description

A recall for this issue was initiated on (b)(4) 2015.While the panoramic x-ray machine was being lowered, the machine slipped and struck an adult male on the shoulder and bumped his head.The patient did later go to the e.R.

Manufacturer Narrative

Dental office did not provide further details on patient.(b)(4).

• 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: 4806072
• MDR Text Key: 21933829
• Report Number: 1832462-2015-00003
• 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: Company Representative
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 05/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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?: No
• Date Manufacturer Received: 06/06/2013
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2003
• 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): Hospitalization; Other