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

Model Number TRIDIEN APL 36X80 MATTRESS, CU GAYMAR P2500 APL

Device Problem Insufficient Information (3190)

Patient Problem Fall (1848)

Event Date 02/27/2018

Event Type  Injury  

Event Description

Sitting on the edge of the side of the bed and he slid off.He was transferring from chair to the bed and once he set on the mattress he slid off.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: MATTRESS
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): TRIDEN; GAYMAR
• MDR Report Key: 17526231
• MDR Text Key: 321137252
• Report Number: MW5133171
• 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: 03/16/2018

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, CU GAYMAR P2500 APL
• Device Catalogue Number: 3001020, C2500
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1
• Treatment: FMW AIR FLOTATION, ALERNATING PRESSURE, MATTRESS C
• Patient Age: 66 YR