inforMED
MalfunctionBYP

MICROSPACER

Received May 11, 2023 · Event occurred May 9, 2023

Report MW5117490 · MDR key 16919707

Device

Generic name

Mouthpiece, Breathing

Model number

47360-0172-01

Lot number

0007

Product problems

  • Material Split, Cut or Torn

Patient

53 YR · Female

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

PATIENT WAS PRESCRIBED A MICROSPACER FOR USE WITH AN INHALER. THE MICROSPACER SPLIT AND BECAME UNUSABLE AFTER 3 USES WITH THE INHALER.