inforMED
InjuryILS

AQUASENSE

Received Jan 27, 2016 · Event occurred Jan 25, 2016

Report 8022077-2016-00010 · MDR key 5416109

Device

Generic name

Aquasense Adjustable Bath Seat

Manufacturer

Amg Medical Inc.

Catalog number

770-500

Product problems

  • Material Integrity Problem

Patient

58 YR

  • Fall
  • Fall

Narrative

Additional Manufacturer Narrative

CUSTOMER WAS SITTING ON THE BATH SEAT WHILE TAKING A SHOWER AND FELL. SHE CLAIMS THAT THE MIDDLE SCREW IS STRIPPED. SHE HAS BRUISES ON HER BACK AND BOTTOM. WE SENT HER A REPLACEMENT UNIT AND SHE WILL SEND US THE DEFECTIVE UNIT HERE FOR INVESTIGATION. WE WILL SEND A FOLLOW-UP REPORT INCLUDING THE DEVICE EVALUATION ONCE WE RECEIVE THE UNIT HERE AND THE INVESTIGATION IS DONE.

Description of Event or Problem

CUSTOMER WAS SITTING ON THE BATH SEAT WHILE TAKING A SHOWER AND FELL. SHE CLAIMS THAT THE MIDDLE SCREW IS STRIPPED. SHE HAS BRUISES ON HER BACK AND BOTTOM.