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

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

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

Patient Problem Fall (1848)

Event Date 06/16/2017

Event Type  Injury  

Event Description

Per (b)(6) lpn; as staff attempted to roll patient to insert bed frame; he rolled over the bolsters and fell.No medical treatment needed; no scrapes and/or bruising etc.(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: 17534092
• MDR Text Key: 321069095
• Report Number: MW5140995
• 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: 06/20/2017

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 5000 AP CONTROL UNIT, TRIDIEN APL 36X80 MATTRESS
• Patient Sequence Number: 1
• Patient Age: 75 YR