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MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-12-28 for * manufactured by Duro-med Industries.

Event Text Entries

[16101060] Patient (b)(6) sat on bedside commode. The seat and the container collapsed onto the floor with patient ending up wedged in the frame. The weight limit of the bedside commode was 250 lbs. Hospital maintenance staff put together the bedside commode, as it is not shipped as a whole unit. Unsure if this caused the error or if the equipment was at fault.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2892096
• MDR Report Key: 2892096
• Date Received: 2012-12-28
• Date of Report: 2012-12-28
• Date of Event: 2012-03-30
• Report Date: 2012-12-28
• Date Reported to FDA: 2012-12-28
• Date Added to Maude: 2013-01-02
• 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: 3
• 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 Details

• Brand Name: *
• Generic Name: BODY WASTE RECEPTACLE
• Product Code: FLH
• Date Received: 2012-12-28
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DURO-MED INDUSTRIES
• Manufacturer Address: 1788 W. CHERRY ST. JESUP GA 31545 US 31545

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-12-28