MAUDE Adverse Event Report: INTEGRA YORK, PA INC. CARBIDE BURS - FG 558SU PACK OF 10; M51 - GENERAL DENTISTRY

Catalog Number DFG558SU

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Customer initially reports breaking.March 10, 2014 customer reports no harm done.Event details not available.Preventative measures used in general to prevent swallowing.

Manufacturer Narrative

To date the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported information.

• Brand Name: CARBIDE BURS - FG 558SU PACK OF 10
• Type of Device: M51 - GENERAL DENTISTRY
• Manufacturer (Section D): INTEGRA YORK, PA INC.; york PA
• Manufacturer (Section G): MILTEX, INC.; 589 davies drive; york PA 17402
• Manufacturer Contact: sandra lee ; 315 enterprise drive; 6099366828
• MDR Report Key: 3807237
• MDR Text Key: 16223884
• Report Number: 2523190-2014-00015
• Device Sequence Number: 1
• Product Code: EJL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2014

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: DFG558SU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2014
• Initial Date FDA Received: 03/20/2014
• 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