inforMED
MalfunctionCAN

MEDITEC

Received May 2, 2024 · Event occurred Jan 10, 2024

Report 3003207908-2024-00001 · MDR key 19227588

Device

Generic name

Meditec

Manufacturer

Gce, S.r.o.

Model number

0721109US

Catalog number

0721109US

Lot number

0000226073

Product problems

  • Inaccurate Information
  • Inaccurate Information

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

THE BOX LABEL HAS THE WRONG FINAL PRODUCT NUMBER (REF). THERE WAS COMPLETELY CORRECT MARKING ON THE MEDICAL DEVICE.

Additional Manufacturer Narrative

THERE WAS COMPLETELY CORRECT MARKING ON THE MEDICAL DEVICE. THE BOX LABEL INCLUDES THE WRONG FINAL PRODUCT NUMBER (REF). THE WHOLE DELIVERY WAS ISOLATED AND RELABELLED BY CORRECT BOX LABEL BEFORE RELEASE TO THE FOLLOWING DISTRIBUTION.