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

Model Number TRIDIEN APL 36X80 MATTRESS, TRIDIEN STAT 5000 AP CU

Device Problem Positioning Problem (3009)

Patient Problem Bruise/Contusion (1754)

Event Date 05/21/2017

Event Type  Injury  

Event Description

Resident found on floor.Mattress exceeding height of the horse shoe railing.Small bruise to the head.They reference it as a knot.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: 17530488
• MDR Text Key: 321090312
• Report Number: MW5137408
• 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: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: TRIDIEN APL 36X80 MATTRESS, TRIDIEN STAT 5000 AP CU
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1