MAUDE Adverse Event Report: INTEGRA YORK, PA INC. MIRROR - DBL SIDED, SZ 5; M52 - HYGIENE / PERIODONTAL

Catalog Number 67723

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.

Event Description

Customer initially reports 2 mirrors from a package had the mirror part fall off.They already disposed of the product so there is nothing to send in for rma complaint.On (b)(6) 2015 customer reports doctor was examining patient when mirror fell out of frame in mouth, no harm done, easily retrieved.

• Brand Name: MIRROR - DBL SIDED, SZ 5
• Type of Device: M52 - HYGIENE / PERIODONTAL
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• Manufacturer (Section G): INTEGRA YORK, PA INC.; 589 davies drive; york PA 17402
• Manufacturer Contact: sandra lee ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5212041
• MDR Text Key: 30836259
• Report Number: 2523190-2015-00114
• Device Sequence Number: 1
• Product Code: EAX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Dental Assistant
• Type of Report: Initial
• Report Date: 10/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 67723
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2015
• 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