AMERICAN STANDARD *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-12-27 for AMERICAN STANDARD * manufactured by American Standard.

Event Text Entries

[17903072] Title: patient fall due to broken toilet seat. The patient was using a [permanent] commode and a raised toilet seat [with arms]which was broken. [the seat broke away at the hinge which was visible only upon close inspection after the patient had fallen. ] the patient slipped and fell off of the seat and bumped their head. The patient was sent to the emergency department for evaluation and xrays. [this permanent commode was located in the patient bathroom. Normal wear was stated as a cause but there were no visible signs of disrepair. The inspection process for this type of device is every 12 months during scheduled room inspections. The patient did not have assistance in using the device at the time of the event. This has not happened with this device previously at this facility. There were no unusual circumstances or activities surrounding this event]. Device usage problem: device failed (e. G. Broke, couldn't get it to work or stopped working).
Patient Sequence No: 1, Text Type: D, B5

[18010929]
Patient Sequence No: 2, Text Type: D, B5

MAUDE Entry Details

• Report Number: 434663
• MDR Report Key: 434663
• Date Received: 2002-12-27
• Date of Report: 2002-04-04
• Date of Event: 2002-03-13
• Report Date: 2002-04-04
• Date Reported to FDA: 2002-04-11
• Date Added to Maude: 2002-12-31
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: AMERICAN STANDARD
• Generic Name: TOILET
• Product Code: IKW
• Date Received: 2002-12-27
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Age: 20 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 423614
• Manufacturer: AMERICAN STANDARD
• Manufacturer Address: 865 CENTENNIAL AVENUE PISCATAWAY NJ 08855 US

Device Sequence Number: 2

• Brand Name: AMERICAN STANDARD
• Generic Name: TOILET LID [RAISED TOILET SEAT]
• Product Code: IKW
• Date Received: 2002-12-27
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Age: 20 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 423645
• Manufacturer: AMERICAN STANDARD
• Manufacturer Address: 865 CENTENNIAL AVENUE PISCATAWAY NJ 08855 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2002-12-27
2	0		2002-12-27