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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENDEX DENTAL SYSTEMS 765 DC EXTRAORAL SOURCE X-RAY SYSTEM

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GENDEX DENTAL SYSTEMS 765 DC EXTRAORAL SOURCE X-RAY SYSTEM Back to Search Results
Model Number 765DC
Device Problem Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/27/2017
Event Type  malfunction  
Manufacturer Narrative
The unit has been in use since (b)(6) 2005. The model was discontinued in august 2007. The device will not be returned to the manufacturer for further investigation as the device has already been scrapped by the dental office. No evaluation could be performed on the device. There were no serious injuries reported. The distributor confirmed that the lag bolts pulled out of the wall and was not related to the device itself. This concludes the investigation.
 
Event Description
It was reported that the x-ray fell off the wall and struck a patient. After contacting the dental office, it was reported that the patient is a (b)(6) male who received a scratch. There was no medical intervention reported. No other injries were reported.
 
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Brand Name765 DC
Type of DeviceEXTRAORAL SOURCE X-RAY SYSTEM
Manufacturer (Section D)
GENDEX DENTAL SYSTEMS
1910 north penn road
hatfield PA 19440
Manufacturer (Section G)
IMAGING SCIENCES INTERNATIONAL/GENDEX/DEXIS
2800 crystal drive
hatfield PA 19440
Manufacturer Contact
erika martin
2800 crystal drive
hatfield, PA 19440
7045877241
MDR Report Key7269261
MDR Text Key100247230
Report Number2530069-2018-00001
Device Sequence Number1
Product Code EHD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K992610
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Service Personnel
Type of Report Initial
Report Date 02/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Dentist
Device Model Number765DC
Device Catalogue Number0.820.0144
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/16/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/05/2005
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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