inforMED
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

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.