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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC E3 6:1 CONTRA ANGLE; CONTROLLER, FOOT, HANDPIECE AND CORD
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TULSA DENTAL PRODUCTS LLC E3 6:1 CONTRA ANGLE; CONTROLLER, FOOT, HANDPIECE AND CORD Back to Search Results
Catalog Number E3CONTRA
Device Problems Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
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 results are not available as of this report.Evaluation results will be submitted as they become available.
 
Event Description
In this event it was reported that an e3 contra angle won't hold files; no injury resulted.
 
Manufacturer Narrative
Evaluation found the contra angle is defective.
 
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Brand Name
E3 6:1 CONTRA ANGLE
Type of Device
CONTROLLER, FOOT, HANDPIECE AND CORD
Manufacturer (Section D)
TULSA DENTAL PRODUCTS LLC
608 rolling hills drive
johnson city TN 37604
MDR Report Key8802737
MDR Text Key151602509
Report Number2320721-2019-00135
Device Sequence Number1
Product Code EBW
Combination Product (y/n)N
PMA/PMN Number
K103653
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 10/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberE3CONTRA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/02/2019
Date Manufacturer Received08/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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