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

Model Number TRIDIEN 36X80 APL MATTRESS, TRIDIEN CONTROL UNIT , 3001020, STAT 5000

Device Problem Product Quality Problem (1506)

Patient Problems Fall (1848); Skin Tears (2516)

Event Date 02/19/2017

Event Type  Injury  

Event Description

During morning care, patient was on her side close to the edge, rolled off and could not stop herself because the mattress was slick and didn't have bolsters.She fell on the floor, slid on down the bed while holding the bar.Skin tear to one of her legs, first aide was received.(b)(4).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: 17531274
• MDR Text Key: 321137747
• Report Number: MW5138189
• 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: 02/24/2017

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 36X80 APL MATTRESS, TRIDIEN CONTROL UNIT , 3001020, STAT 5000
• Patient Sequence Number: 1
• Patient Age: 79 YR