MIRROR - DBL SIDED, SZ 4 67722

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,08 report with the FDA on 2012-01-16 for MIRROR - DBL SIDED, SZ 4 67722 manufactured by Integra York, Pa Inc..

Event Text Entries

[16411969] The mirror seemed to come unglued and fell into a patient's mouth. The mirror was retrieved and there was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5

[16569516] 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.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 2523190-2012-00010
• MDR Report Key: 2437929
• Report Source: 05,06,08
• Date Received: 2012-01-16
• Date of Report: 2012-01-16
• Date Mfgr Received: 2012-01-13
• Date Added to Maude: 2012-08-06
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: DENTIST
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: CAREN FERNANDEZ
• Manufacturer Street: 315 ENTERPRISE DRIVE
• Manufacturer City: PLAINSBORO NJ 08536
• Manufacturer Country: US
• Manufacturer Postal: 08536
• Manufacturer Phone: 6099362341
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MIRROR - DBL SIDED, SZ 4
• Generic Name: M52 - HYGIENE/PERIODONTAL
• Product Code: EAX
• Date Received: 2012-01-16
• Catalog Number: 67722
• Lot Number: 02623
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: INTEGRA YORK, PA INC.
• Manufacturer Address: YORK PA 17402 US 17402

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-01-16