TOILET SEAT 5.5 INCH 300LB

Additional Manufacturer Narrative

BASED ON THE SUPPLIER¿S INVESTIGATION, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS A LOT NUMBER WAS NOT PROVIDED. THE DEVICE MASTER RECORD FOR THIS PRODUCT WAS REVIEWED AND THERE HAVE BEEN NO CHANGES IN MATERIAL, DESIGN OR PRODUCTION PROCESS. AS THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION, THE ROOT CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED FROM THIS INVESTIGATION. THE COMPLAINT INFORMATION WAS PROVIDED TO THE RELEVANT SECTORS FOR THEIR AWARENESS. THERE IS NO ADDITIONAL ACTION TAKEN AT THIS TIME, BUT THE SUPPLIER WILL CONTINUE TO MONITOR THE TREND OF THIS TYPE OF INCIDENT.

Description of Event or Problem

(B)(6) CALLED IN STATING HIS WIFE FELL ON (B)(6) 2018 AND INJURED HER KNEES WHEN THE TOILET SEAT SLID FROM THE COMMODE AS SHE WAS GETTING UP. SHE WENT TO AN ORTHOPEDIC SURGEON AND HE WITHDREW FLUID FROM HER KNEES.