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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Bruise/Contusion (1754)

Event Date 12/23/2016

Event Type  Injury  

Manufacturer Narrative

This machine was sold by the original owner and was relocated without our knowledge or assistance.

Event Description

* a recall for this issue was initiated on 23-apr-2015.Dr (b)(6) called and stated that his pc-1000 serial number (b)(4) came down and hit his employee in the head about 7-10 days ago.She went ot the hospital and received an mri and ct scan.It was reported that she has no broken bones only bruises across her back, neck and side of her face.The machine 10729 was sold and moved to dr (b)(6) practice.He was unaware of the recall.

• Brand Name: PANORAMIC X-RAY PC-1000
• Type of Device: PC-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: 6277761
• MDR Text Key: 65746069
• Report Number: 1832462-2017-00003
• Device Sequence Number: 1
• Product Code: EHD
• UDI-Device Identifier: 00862309000309
• UDI-Public: 00862309000309
• 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: health professional,user faci
• Reporter Occupation: Dental Assistant
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 01/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dental Hygienist
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2000
• 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