MAUDE Adverse Event Report: DENTSPLY TULSA DENTAL SPECIALTIES PROLUBE ROOT CANAL CONDITIONER; SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING

Catalog Number PROLUBE100

Device Problem Overfill (2404)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

The symptoms described in this event are consistent with other events where dental material was extruded beyond the apex.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.This report is for the second patient.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.

Event Description

In this event it was reported that two patients experienced an adverse reaction after a root canal where prolube root canal conditioner was used.The dentist reported that slight necrosis was evident in a patient.The patient has pain and a tingling sensation in the lip.Radiographs are not yet available for review.

• Brand Name: PROLUBE ROOT CANAL CONDITIONER
• Type of Device: SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING
• Manufacturer (Section D): DENTSPLY TULSA DENTAL SPECIALTIES; 608 rolling hills drive; johnson city TN 37604
• Manufacturer (Section G): DENTSPLY CAULK; 38 w. clark ave.; milford DE 19963
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 5151508
• MDR Text Key: 28295043
• Report Number: 2515379-2015-00060
• Device Sequence Number: 1
• Product Code: EIC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972234
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Report Date: 09/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Catalogue Number: PROLUBE100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other