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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC X-SMART IQ MOTOR HANDPIECE; CONTROLLER, FOOT, HANDPIECE AND CORD
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TULSA DENTAL PRODUCTS LLC X-SMART IQ MOTOR HANDPIECE; CONTROLLER, FOOT, HANDPIECE AND CORD Back to Search Results
Catalog Number XSIQEM1HP
Device Problem Unintended Electrical Shock (4018)
Patient Problems Electric Shock (2554); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such.This event, therefore, is reportable per 21cfr part 803.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.
 
Event Description
It was reported that a xsmart iq motor handpiece shocked a dental assistant when removing from the charger; no injury resulted.
 
Manufacturer Narrative
A visual inspection of the returned product found that the casing was actually broken at the charging area.The hp was damaged when plugging in to charge which may have led to the hp shocking the user.
 
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Brand Name
X-SMART IQ MOTOR HANDPIECE
Type of Device
CONTROLLER, FOOT, HANDPIECE AND CORD
Manufacturer (Section D)
TULSA DENTAL PRODUCTS LLC
608 rolling hills drive
johnson city TN 37604
MDR Report Key11376688
MDR Text Key234675536
Report Number2320721-2021-00005
Device Sequence Number1
Product Code EBW
Combination Product (y/n)N
PMA/PMN Number
K161213
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 03/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberXSIQEM1HP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/16/2021
Date Manufacturer Received01/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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