inforMED
MalfunctionILM

SITZ BATH 1616700692

Received Sep 18, 2015

Report 1525712-2015-04579 · MDR key 5087211

Device

Generic name

Bath, Sitz, Nonpowered

Model number

IH1900IH3652GW

Product problems

  • Leak/Splash

Patient

Not reported

  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

PRODUCT WAS RETURNED FOR EVALUATION. THE RETURN FIELDS IN ORACLE STATE: PLUMBING UNABLE TO TEST. NO TEST FIXTURE. COMPLAINT WAS NOT CONFIRMED. THE UNDERLYING CAUSE COULD NOT BE DETERMINED AFTER REVIEWING THE DOCUMENTATION IN THIS INVESTIGATION.

Description of Event or Problem

PRODUCT WAS RETURNED FOR EVALUATION. THE RETURN FIELDS IN ORACLE STATE: PLUMBING UNABLE TO TEST. NO TEST FIXTURE. TUB WAS LEAKING AT THE BOTTOM OF THE DOOR.

Additional Manufacturer Narrative

A RETURN WAS ISSUED AND THE PRODUCT IS AWAITING RECEIPT AND/OR EVALUATION. A FOLLOW UP WILL BE FILED IF/WHEN ANY ADDITIONAL INFORMATION IS PROVIDED.

Description of Event or Problem

TUB WAS LEAKING AT THE BOTTOM OF THE DOOR.