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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC PROULTRA SINE TIP #3; SCALER, ULTRASONIC
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TULSA DENTAL PRODUCTS LLC PROULTRA SINE TIP #3; SCALER, ULTRASONIC Back to Search Results
Catalog Number PUSINE3
Device Problem Break (1069)
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 with a similar device 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
In this event it was reported that a proultra sine tip #3 broke during use; no injury resulted.
 
Manufacturer Narrative
Multiple unsuccessful attempts were made to obtain the device for evaluation.
 
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Brand Name
PROULTRA SINE TIP #3
Type of Device
SCALER, ULTRASONIC
Manufacturer (Section D)
TULSA DENTAL PRODUCTS LLC
608 rolling hills drive
johnson city TN 37604
MDR Report Key8196687
MDR Text Key131595795
Report Number2320721-2018-00195
Device Sequence Number1
Product Code ELC
Combination Product (y/n)N
PMA/PMN Number
K960889
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 02/14/2019
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 NumberPUSINE3
Device Lot Number191770
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 11/30/2018
Initial Date FDA Received12/26/2018
Supplement Dates Manufacturer Received01/17/2019
Supplement Dates FDA Received02/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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