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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY LLC 30K THINSERT ULTRASONIC INSERT; SCALER, ULTRASONIC
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DENTSPLY LLC 30K THINSERT ULTRASONIC INSERT; SCALER, ULTRASONIC Back to Search Results
Catalog Number 81551
Device Problem Overheating of Device (1437)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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.Multiple unsuccessful attempts were made to obtain the device for evaluation.The device was not returned for evaluation.However, the lot number was provided and retained-product testing and/or dhr review are planned.The results will be submitted as they become available.
 
Event Description
While using a 30k cavitron thinsert, the insert was overheating; no injury resulted.
 
Manufacturer Narrative
Multiple unsuccessful attempts were made to obtain the device for evaluation.
 
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Brand Name
30K THINSERT ULTRASONIC INSERT
Type of Device
SCALER, ULTRASONIC
Manufacturer (Section D)
DENTSPLY LLC
1301 smile way
york PA 17404
MDR Report Key9566714
MDR Text Key186733516
Report Number2424472-2019-00218
Device Sequence Number1
Product Code ELC
Combination Product (y/n)N
PMA/PMN Number
K052334
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 02/28/2020
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 Number19291
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/02/2019
Initial Date FDA Received01/08/2020
Supplement Dates Manufacturer Received12/02/2019
Supplement Dates FDA Received02/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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