inforMED
MalfunctionILJ

SITZ BATH 1616700692

Received Jan 4, 2016

Report 1219590-2015-00196 · MDR key 5339866

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

SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A SUPPLEMENTAL RECORD WILL BE FILED.

Description of Event or Problem

THE DEALER STATES THAT THE SEAL IS BEGINING TO LEAK AND THEY NEED A REPLACEMENT SEAL.