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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARIBEX NOMAD DENTAL EXTRAORAL SOURCE X-RAY SYSTEM

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ARIBEX NOMAD DENTAL EXTRAORAL SOURCE X-RAY SYSTEM Back to Search Results
Model Number 0.850.0000
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problem Breast Mass (2439)
Event Date 05/16/2017
Event Type  Injury  
Manufacturer Narrative
The unit was returned to aribex and an internal investigation was conducted, as well as, an evaluation by an independent physics service. The unit was found to be within all specifications and no damage was found to the unit. Based on measurements made on the unit, the maximum exposure rate to an operator of the device is significantly below the applicable dose limits to both body and hands of the operator of the unit. The evaluation concluded that the unit is operating as expected and within established performance specifications. Aribex is unable to confirm the complaint. This concludes the investigation.
 
Manufacturer Narrative
The unit has been returned and will be evaluated by a third party. Specific patient information is not yet available. A follow-up report will be submitted upon evaluation completion.
 
Event Description
It was reported by the office manager that a doctor found a lump in the breast of a dental hygienist in the office and they believe that the nomad dental x-ray system is a contributing factor. The dental office asked to have the unit evaluated for extra exposure.
 
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Brand NameNOMAD DENTAL
Type of DeviceEXTRAORAL SOURCE X-RAY SYSTEM
Manufacturer (Section D)
ARIBEX
11727 fruehauf drive
charlotte NC 28273
Manufacturer (Section G)
ARIBEX
11727 fruehauf drive
charlotte NC 28273
Manufacturer Contact
erika martin
11727 fruehauf drive
charlotte, NC 28273
7045877241
MDR Report Key6640303
MDR Text Key208303856
Report Number1017522-2017-00036
Device Sequence Number1
Product Code EHD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051795
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Dental Hygienist
Device Model Number0.850.0000
Device Catalogue Number0.850.0000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/19/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/16/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/23/2014
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: 06/14/2017 Patient Sequence Number: 1
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