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

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

Device Problem Device Slipped (1584)

Patient Problem Fall (1848)

Event Date 04/11/2017

Event Type  Injury  

Event Description

The patient slipping off the mattress and onto the floor.The patient said that he ended up on the floor is because he was sitting on the edge of the mattress and it is slippery.He fell onto the floor.The patient called for help.(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: 17527592
• MDR Text Key: 321079596
• Report Number: MW5134524
• 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: 04/17/2017

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 5000AP CONTROL UNIT
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1
• Patient Age: 69 YR