MAUDE Adverse Event Report: TRIDIEN TRIDIEN APL MATTRESS; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number TRIDIEN STAT 4 AP MATTRESS, TRIDIEN STAT AP CONTROL UNIT, 3001012, SR309

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Insufficient Information (4580)

Event Date 11/15/2007

Event Type  Injury  

Event Description

She fell out of bed.She was found tangled up in bed with her knees to her chest and laying on her side.She has a gash on left eyebrow.She was sent to the er to get staples and xrays.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: TRIDIEN APL MATTRESS
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): TRIDIEN
• MDR Report Key: 17536134
• MDR Text Key: 321140954
• Report Number: MW5143024
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: TRIDIEN STAT 4 AP MATTRESS, TRIDIEN STAT AP CONTROL UNIT, 3001012, SR309
• Patient Sequence Number: 1
• Patient Age: 85 YR