MAUDE Adverse Event Report: PANORAMIC CORP. PANORAMIC X-RAY MODEL LASER-1000; PC-1000/LASER1000

Model Number 800724-3

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

Patient Problem Contusion (1787)

Event Date 02/05/2009

Event Type  Injury  

Event Description

A recall for this issue was initiated on (b)(6) 2015.Machine's overhead dropped and bumped the patient's head.She said the patient appeared okay and would be alright.

Manufacturer Narrative

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

• Brand Name: PANORAMIC X-RAY MODEL LASER-1000
• Type of Device: PC-1000/LASER1000
• Manufacturer (Section D): PANORAMIC CORP.; fort wayne IN
• Manufacturer Contact: 4321 goshen rd.; fort wayne, IN 46818 ; 8006542027
• MDR Report Key: 4806094
• MDR Text Key: 5921002
• Report Number: 1832462-2015-00018
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K882436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• 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: 800724-3
• Device Lot Number: 6000 - 13885
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2009
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/1998
• 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