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

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Joint Dislocation (2374)

Event Date 08/22/2018

Event Type  Injury  

Event Description

An unwitnessed fall; she somehow wiggled her way from the bed on to the floor; she partially dislocated her right hip.Were there any injuries? yes.Was medical attention required? yes.Hospital name: (b)(6) medical center of (b)(6).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): TRIDIEN
• MDR Report Key: 17533524
• MDR Text Key: 321161313
• Report Number: MW5140428
• 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: 08/27/2018

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
• Patient Sequence Number: 1
• Patient Age: 86 YR