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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY PROFESSIONAL 30K THINSERT ULTRASONIC INSERT; SCALER, ULTRASONIC

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DENTSPLY PROFESSIONAL 30K THINSERT ULTRASONIC INSERT; SCALER, ULTRASONIC Back to Search Results
Catalog Number 81551
Device Problem Overheating of Device (1437)
Patient Problem Partial thickness (Second Degree) Burn (2694)
Event Type  malfunction  
Manufacturer Narrative
While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event 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
While using a cavitron 30k thinsert, the insert was getting hot.The hygienist stated the insert caused a small blister on their finger that has since remediated.No medical attention was required.
 
Manufacturer Narrative
The returned device was evaluated and found to have a clogged tip.When the tip is clogged, the insert tends to get hot because there is no water to keep the tip cool.Also, a dhr review was conducted with no discrepancies noted.
 
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Brand Name
30K THINSERT ULTRASONIC INSERT
Type of Device
SCALER, ULTRASONIC
Manufacturer (Section D)
DENTSPLY PROFESSIONAL
1301 smile way
york PA 17404
Manufacturer (Section G)
DENTSPLY PROFESSIONAL
1301 smile way
york PA 17404
Manufacturer Contact
helen lewis
221 w. philadelphia st.
suite 60w
york, PA 17401
7178494229
MDR Report Key5718549
MDR Text Key48200508
Report Number2424472-2016-00042
Device Sequence Number1
Product Code ELC
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K052334
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Dentist
Type of Report Initial,Followup
Report Date 05/11/2016
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 Catalogue Number81551
Device Lot Number5210
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/11/2016
Initial Date FDA Received06/10/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received07/18/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age68 YR
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