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

Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/21/2016
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: PC-1000 / LASER-1000
• Manufacturer (Section D): PANORAMIC CORPORATION; 4321 goshen road; fort wayne IN 46818
• MDR Report Key: 6263463
• Report Number: 1832462-2017-00002
• Device Sequence Number: 16351449
• Product Code: EHD
• UDI-Device Identifier: 00862309000316
• UDI-Public: 00862309000316
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K882436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Dental Assistant
• Type of Report: Initial
• Report Date (Section B): 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Dental Hygienist
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2016
• Initial Report FDA Received Date: 01/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 15 YR