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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENDEX GENDEX EXPERT DC; DENTAL EXTRA ORAL SOURCE X-RAY UNIT
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GENDEX GENDEX EXPERT DC; DENTAL EXTRA ORAL SOURCE X-RAY UNIT Back to Search Results
Model Number EXPERT DC
Device Problem Component Falling (1105)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/03/2014
Event Type  malfunction  
Event Description
The hygienist was taking bitewing x-ray of a pt when device fell into the wall suddenly.The hygienist was hit on the head and shoulder region, and sustained minor injury (bruise).She did not seek medical intervention.The pt was in the chair but unaffected.The hygienist has fully recovered.
 
Manufacturer Narrative
The device has not been returned to the mfr for eval at time of this report.Upon completion of the eval, a f/u will be submitted.
 
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Brand Name
GENDEX EXPERT DC
Type of Device
DENTAL EXTRA ORAL SOURCE X-RAY UNIT
Manufacturer (Section D)
GENDEX
des plaines IL
Manufacturer Contact
ruth pui
2800 crystal dr.
hatfield, PA 19440
2679541479
MDR Report Key4239722
MDR Text Key15344619
Report Number2530069-2014-00010
Device Sequence Number1
Product Code EHD
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K992610
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 10/03/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberEXPERT DC
Device Catalogue Number1.006.2581
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/03/2014
Initial Date FDA Received10/31/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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