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

Model Number 800724-3

Device Problem Break (1069)

Patient Problem Contusion (1787)

Event Date 06/02/2015

Event Type  Injury  

Event Description

Machine came crashing down, sounded like glass breaking.It hit the patient and the patient went to the emergency room.It also hit the assistant's arm.Both the patient and the assistant are reported as being fine.

Manufacturer Narrative

A recall for this issue was initiated on 4/23/2015.No further information on patient or assistant.

• 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: 4881482
• MDR Text Key: 5865908
• Report Number: 1832462-2015-00021
• 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
• Reporter Occupation: Dentist
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 06/08/2015

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: 800724-3
• Device Lot Number: 6000-13885
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2001
• 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): Hospitalization; Other