MIRROR - DBL SIDED, SZ 5 67723

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-08-09 for MIRROR - DBL SIDED, SZ 5 67723 manufactured by Integra, York - Imiltex.

Event Text Entries

[2268477] The customer initially reported that the mirror fell out into pt's mouth. No pt injury. On (b)(6) 2011, customer confirms no pt injury, but is concerned about the potential for a pt to swallow the mirror and be harmed.
Patient Sequence No: 1, Text Type: D, B5

[9397873] To date the device involved in the reported incident has not been received for eval. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 2523190-2011-00058
• MDR Report Key: 2220037
• Report Source: 06
• Date Received: 2011-08-09
• Date of Report: 2011-08-09
• Date Mfgr Received: 2011-08-03
• Date Added to Maude: 2012-06-18
• 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
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: SANDRA LEE
• Manufacturer Street: 589 DAVIES DRIVE
• Manufacturer City: YORK PA 17402
• Manufacturer Country: US
• Manufacturer Postal: 17402
• Manufacturer Phone: 6099366828
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MIRROR - DBL SIDED, SZ 5
• Generic Name: M52 - HYGIENE / PERIODONTAL
• Product Code: EAX
• Date Received: 2011-08-09
• Catalog Number: 67723
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: INTEGRA, YORK - IMILTEX
• Manufacturer Address: YORK PA 17402 US 17402

Patients

Patient Number	Treatment	Outcome	Date
1	0		2011-08-09