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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 2003-09-16 for * manufactured by *.

Event Text Entries

[15739559] A patient needed to be accomodated, therefore, a "bed extender" was placed on their bed. This "bed extender" was lightly padded and the patient quickly developed a pressure ulcer on their heel, which required significant medical treatment. The resident was predisposed to development of the pressure ulcer but there were no recommendations or warnings from the manufacturer not to use the device on this type of patient.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 547898
• MDR Report Key: 547898
• Date Received: 2003-09-16
• Date of Report: 2003-09-16
• Date of Event: 2003-06-03
• Report Date: 2003-09-16
• Date Reported to FDA: 2003-09-16
• Date Added to Maude: 2004-10-13
• 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
• 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 Details

• Brand Name: *
• Generic Name: BED EXTENDER
• Product Code: FPS
• Date Received: 2003-09-16
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 537350
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2003-09-16