inforMED
MalfunctionILJ

SITZ BATH 1616700692

Received Apr 25, 2016

Report 1219590-2016-00052 · MDR key 5604217

Device

Generic name

Bath, Sitz, Nonpowered

Model number

IH3650

Product problems

  • Leak/Splash

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

MDR IS BEING SUBMITTED AS A RESULT OF A RETROSPECTIVE COMPLAINT REVIEW.

Description of Event or Problem

CUSTOMER STATES THE DOOR SEAL IS LEAKING.