MAUDE Adverse Event Report: DENTSPLY CAULK AQUASIL ULTRA MONOPHASE FAST SET; MATERIAL, IMPRESSION

Catalog Number 678774

Device Problems Material Too Rigid or Stiff (1544); Improper or Incorrect Procedure or Method (2017)

Patient Problems Injury (2348); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Because this event resulted in medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, it must be presumed that the malfunction would be likely to cause or contribute to a serious injury should it recur.As such, this event meets the definition of a reportable event 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 aquasil ultra monophase had a stiffer/firmer consistency than normal during an impression procedure.A clinician was taking an impression of a patient's tooth that was adjacent to a tooth that had an existing crown.When the clinician removed the impression, the crown and the patient's tooth came out with the impression material.

Manufacturer Narrative

The device was evaluated and found to be within specification.

• Brand Name: AQUASIL ULTRA MONOPHASE FAST SET
• Type of Device: MATERIAL, IMPRESSION
• Manufacturer (Section D): DENTSPLY CAULK; 38 w. clark ave.; milford DE 19963
• 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: 5565165
• MDR Text Key: 42312822
• Report Number: 2515379-2016-00010
• Device Sequence Number: 1
• Product Code: ELW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 678774
• Device Lot Number: 141007
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Disability