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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY PROFESSIONAL CAVITRON 25K P-10 INSERT TIP; ULTRASONIC SCALER
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DENTSPLY PROFESSIONAL CAVITRON 25K P-10 INSERT TIP; ULTRASONIC SCALER Back to Search Results
Catalog Number 6120108
Device Problem Overheating of Device (1437)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
In this event it was reported that a cavitron 25k p-10 insert tip was "too hot when working on pts"; no injury resulted.
 
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 21 cfr part 803.The device is available for eval, though results are not available as of this report.Eval results will be submitted as they become available.
 
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Brand Name
CAVITRON 25K P-10 INSERT TIP
Type of Device
ULTRASONIC SCALER
Manufacturer (Section D)
DENTSPLY PROFESSIONAL
york PA
Manufacturer Contact
helen lewis
221 w. philadelphia st., ste. 60
york, PA 17401
7178457511
MDR Report Key4360374
MDR Text Key5238203
Report Number2424472-2014-00025
Device Sequence Number1
Product Code ELC
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K033705
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 11/17/2014
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 Number6120108
Device Lot Number4028
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer12/04/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/17/2014
Initial Date FDA Received12/17/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/01/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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