inforMED
MalfunctionILJ

SITZ BATH 1616700692

Received Apr 25, 2016

Report 1219590-2016-00044 · MDR key 5604195

Device

Generic name

Bath, Sitz, Nonpowered

Model number

IH3600XL

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

PER PROVIDER, CUSTOMER STATES THE DOOR SEAL IS LEAKING.