MAUDE Adverse Event Report: PANORAMIC CORPORATION PANORAMIC X-RAY PC-1000/LASER-1000; PC-1000 / LASER-1000

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Date 12/21/2016

Event Type  Injury  

Manufacturer Narrative

The machine was not available to panoramic for repair.During a follow up phone call, the dr's office reports that the machine has been repaired and is working properly.No repair information was available.Device not available for evaluation.

Event Description

On december 22, 2016, (b)(6) from dr (b)(6) office called in stating that their machine is drifting down about 6 inches.She reported that on (b)(6) 2016, while a patient was in the machine it began to drift down and the bite stick broke cutting the patient's lip.There was no medical attention required or administered.

• Brand Name: PANORAMIC X-RAY PC-1000/LASER-1000
• Type of Device: PC-1000 / LASER-1000
• Manufacturer (Section D): PANORAMIC CORPORATION; 4321 goshen road; fort wayne IN 46818
• Manufacturer (Section G): PANORAMIC CORPORATION; 4321 goshen road; fort wayne IN 46818
• Manufacturer Contact: tammy shiffler ; 4321 goshen road; fort wayne, IN 46818 ; 8006542027
• MDR Report Key: 6263463
• MDR Text Key: 65253772
• Report Number: 1832462-2017-00002
• Device Sequence Number: 1
• Product Code: EHD
• UDI-Device Identifier: 00862309000316
• UDI-Public: 00862309000316
• 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 faci
• Reporter Occupation: Dental Assistant
• Type of Report: Initial
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dental Hygienist
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/13/2007
• 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
• Patient Age: 15 YR