MalfunctionEAX
MIRROR - DBL SIDED, SZ 5
Received Nov 9, 2015
Report 2523190-2015-00114 · MDR key 5212041
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Product code (EAX)
Model (67723)
Device
Generic name
M52 - Hygiene / Periodontal
Manufacturer
Integra York, Pa Inc.Catalog number
67723
Lot number
UNKNOWN
Product problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.
Description of Event or Problem
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.