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U.S. Department of Health and Human Services

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

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PANORAMIC CORPORATION PANORAMIC X-RAY PC-1000/LASER-1000 PC-1000 / LASER-1000 Back to Search Results
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.
 
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Brand NamePANORAMIC X-RAY PC-1000/LASER-1000
Type of DevicePC-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 Key6263463
MDR Text Key65253772
Report Number1832462-2017-00002
Device Sequence Number1
Product Code EHD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K882436
Number of Events Reported1
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 Received01/19/2017
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/22/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/13/2007
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: 01/19/2017 Patient Sequence Number: 1
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