MAUDE Adverse Event Report: DENTSPLY VDW GMBH GUTTAFUSION PINK OBTURATOR; GUTTA-PERCHA

Catalog Number V041532000025

Device Problems Incorrect Measurement (1383); Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Swelling (2091); No Consequences Or Impact To Patient (2199)

Event Date 10/13/2016

Event Type  Injury  

Manufacturer Narrative

While it is unknown if the guttafusion obturator caused or contributed to the patient's symptoms, it cannot be definitively ruled out.Therefore, this event is reportable per 21 cfr 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 patient experienced swelling and pain all over the face after a root canal treatment where several different products, including a guttafusion obturator, was used.The patient saw a physician and was treated with antibiotics and analgesics.According to the dentist there was no overfilling and sealing was performed.The patient has no history of allergy is doing well now.

Manufacturer Narrative

Charger and file clip not received.Apex locator checked with test box (b)(4) without errors.

Manufacturer Narrative

Customer returned one unopened sleeve ((b)(4) pcs) of size r25, lot 0000122780, which is indicated as the lot matching this complaint.Customer also returned 2 additional packs containing size r40, lot 0000105559 and size r50, lot 0000092885.None of the obturators had been opened.No loose or opened obturators were returned.Visually checked obturators and found no fault with the obturators returned.Follow-up #1 was submitted in error and does not pertain to this mfr report number.

• Brand Name: GUTTAFUSION PINK OBTURATOR
• Type of Device: GUTTA-PERCHA
• Manufacturer (Section D): DENTSPLY VDW GMBH; bayerwaldstrasse 15; munich, 81737 ; GM 81737
• Manufacturer (Section G): DENTSPLY TULSA DENTAL SPECIALTIES; 608 rolling hills drive; johnson city TN 37604
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 5501625
• MDR Text Key: 60423929
• Report Number: 9611053-2016-00057
• Device Sequence Number: 1
• Product Code: EKM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: V041532000025
• Device Lot Number: 158540
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR