MAUDE Adverse Event Report: DENTSPLY MAILLEFER LENTULO PASTE CARRIER; DRILL, DENTAL, INTRAORAL

Catalog Number A002222100200

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

In this event it was reported that a lentulo separated, separated piece was incorporated into the fill.

Manufacturer Narrative

As a result of this malfunction, the potential for surgical intervention exists to preclude injury or illness that would necessitate medical or surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function.This event, therefore, 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.

• Brand Name: LENTULO PASTE CARRIER
• Type of Device: DRILL, DENTAL, INTRAORAL
• Manufacturer (Section D): DENTSPLY MAILLEFER; ballaigues ; SZ
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st. ste. 60; york, PA 17401 ; 7178457511
• MDR Report Key: 4231577
• MDR Text Key: 5063579
• Report Number: 8031010-2014-00009
• Device Sequence Number: 1
• Product Code: DZA
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: EXEMPT
• 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
• Report Date: 09/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A002222100200
• Device Lot Number: 8131200
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/25/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2014
• Initial Date FDA Received: 10/18/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1