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U.S. Department of Health and Human Services

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

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GENDEX DENTAL SYSTEMS GENDEX EXPERT DC EXTRAORAL SOURCE X-RAY SYSTEM Back to Search Results
Model Number 0.822.5214
Device Problem Device Fell (4014)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/07/2019
Event Type  malfunction  
Manufacturer Narrative
An investigation was conducted using interviews and examining three photos of the unit, lag bolts, and wall where it had been attached. It appears that the top bolt came out of the wall and the bottom bolt was bent from the weight of the unit. A root cause could not be determined; however, it appears that the unit had been moved since the initial installation. The re-install may have diminished the wall stud integrity to support the unit. Sales of the expert dc were discontinued on june 24, 2016. This concludes the investigation.
 
Event Description
It was reported that the unit fell off the wall. It was reported that unit was caught by the hygienist and hit the patient in the leg, but there was no injury reported for the patient or the operator (hygienist). Unit was reattached to the wall.
 
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Brand NameGENDEX EXPERT DC
Type of DeviceEXTRAORAL SOURCE X-RAY SYSTEM
Manufacturer (Section D)
GENDEX DENTAL SYSTEMS
1910 north penn road
hatfield PA 19440
Manufacturer (Section G)
GENDEX DENTAL SYSTEMS
1910 north penn road
hatfield PA 19440
Manufacturer Contact
erika martin
1910 north penn road
hatfield, PA 19440
MDR Report Key8638116
MDR Text Key147340658
Report Number2530069-2019-00004
Device Sequence Number1
Product Code EHD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K996210
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 05/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0.822.5214
Device Catalogue NumberEXPERT DC65 NA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/07/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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