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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY PROFESSIONAL 30K FOCUSED SPRAY SLIMLINE ULTRASONIC INSERT - 1000 (LOW-HIGH POWER); SCALER, ULTRASONIC
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DENTSPLY PROFESSIONAL 30K FOCUSED SPRAY SLIMLINE ULTRASONIC INSERT - 1000 (LOW-HIGH POWER); SCALER, ULTRASONIC Back to Search Results
Catalog Number 81570
Device Problems Overheating of Device (1437); Temperature Problem (3022)
Patient Problem No Consequences Or Impact To Patient (2199)
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 has not been returned as of this report.Evaluation results will be submitted as they become available.
 
Event Description
While using a 30k fsi-sli-1000 insert, the insert was getting hot; no injury resulted.
 
Manufacturer Narrative
The device was not returned for evaluation and the lot number that was provided is incomplete.
 
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Brand Name
30K FOCUSED SPRAY SLIMLINE ULTRASONIC INSERT - 1000 (LOW-HIGH POWER)
Type of Device
SCALER, ULTRASONIC
Manufacturer (Section D)
DENTSPLY PROFESSIONAL
1301 smile way
york PA 17404
MDR Report Key7500560
MDR Text Key107986372
Report Number2424472-2018-00061
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 07/12/2018
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 Number81570
Device Lot Number17248
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/09/2018
Initial Date FDA Received05/09/2018
Supplement Dates Manufacturer Received06/14/2018
Supplement Dates FDA Received07/12/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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