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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC PROMARK FOOT PEDAL HANDPIECE, DIRECT DRIVE, AC-POWERED

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TULSA DENTAL PRODUCTS LLC PROMARK FOOT PEDAL HANDPIECE, DIRECT DRIVE, AC-POWERED Back to Search Results
Catalog Number PMKEM1PDL
Device Problem Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/12/2020
Event Type  malfunction  
Manufacturer Narrative
There has been a previous report received where this malfunction has caused file separation. Since separation of a file could necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, this malfunction would be likely to cause/contribute to a serious injury should it recur. As such, this event meets the criteria for reportability per 21 cfr part 803. " the covid-19 pandemic caused a disruption in normal business activities, resulting in late submission of this report.
 
Event Description
It was reported that a promark endo motor foot pedal was malfunctioning causing the motor to run by its self.
 
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Brand NamePROMARK FOOT PEDAL
Type of DeviceHANDPIECE, DIRECT DRIVE, AC-POWERED
Manufacturer (Section D)
TULSA DENTAL PRODUCTS LLC
608 rolling hills drive
johnson city, tn
Manufacturer (Section G)
ASEPTICO, INC
8333 216th st se
woodinville, wa
Manufacturer Contact
karl nittinger
221 w. philadelphia st.
suite 60w
york, pa 
8494424
MDR Report Key10370950
MDR Text Key202358566
Report Number2320721-2020-00050
Device Sequence Number1
Product Code EKX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111078
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/05/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberPMKEM1PDL
Device Lot NumberEMT2702018-00-067
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/12/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

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