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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PANORAMIC CORPORATION PANORAMIC X-RAY MODEL PC-1000
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PANORAMIC CORPORATION PANORAMIC X-RAY MODEL PC-1000 Back to Search Results
Model Number 800724-1
Device Problem Migration or Expulsion of Device (1395)
Patient Problem Injury (2348)
Event Date 06/16/2016
Event Type  malfunction  
Event Description
Office called, stated the machine unexpectedly dropped about 3 feet.The machine had been making unusual noises before this event.A patient received a glancing blow to the forehead.He has been reported as being fine.No additional medical attention was sought.
 
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Brand Name
PANORAMIC X-RAY MODEL 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
stephen yaggy
4321 goshen road
fort wayne, IN 46818
8006542027
MDR Report Key5798559
MDR Text Key49679485
Report Number1832462-2016-00005
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 Dentist
Remedial Action Replace
Type of Report Initial
Report Date 07/15/2016
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
Device Operator Dentist
Device Model Number800724-1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/07/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/16/2016
Initial Date FDA Received07/15/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/16/1998
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age17 YR
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