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

Model Number VAL_LAL_3680RSR (STAT 5000C)

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

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Date 10/14/2020

Event Type  Injury  

Event Description

Caller (b)(6) stated he asked for a dermafloat matt.He didn't receive it instead above mattress was delivered.When nurse went to change patient she found him laying on the floor on his back.Bed frame was in lowest height setting.Don would like to also note that this is patients second fall, patient didn't receive treatment for first fall.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: TRIDIEN MATTRESS
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): TRIDIEN
• MDR Report Key: 17531402
• MDR Text Key: 321135009
• Report Number: MW5138317
• 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: 11/19/2020

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: VAL_LAL_3680RSR (STAT 5000C)
• Device Catalogue Number: R120255 R168134
• Patient Sequence Number: 1
• Patient Age: 78 YR