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U.S. Department of Health and Human Services

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

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PANORAMIC CORPORATION PANORAMIC X-RAY PC-1000 Back to Search Results
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.
 
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Brand NamePANORAMIC X-RAY PC-1000
Type of DevicePC-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 Key6277761
MDR Text Key65746069
Report Number1832462-2017-00003
Device Sequence Number1
Product Code EHD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K870236
Number of Events Reported1
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 Received01/25/2017
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/30/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/11/2000
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 01/25/2017 Patient Sequence Number: 1
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