MAUDE Adverse Event Report: TRIDIEN MATTRESS COVER FOR MEDICAL PURPOSES.; COVER, MATTRESS (MEDICAL PURPOSES)

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 06/05/2018

Event Type  Death  

Event Description

I received a call from (b)(6) hc and rehab regarding service order (b)(4).Per (b)(6) after the equipment was delivered the patient was then placed onto the mattress, once he was put on to the mattress the patient then stopped breathing.(b)(6) proceeded to inform me that the paramedics were called and came out to try and revive the patient.Were there any injuries? : yes.Was medical attention required ?: yes.What were the injuries? : death.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: MATTRESS COVER FOR MEDICAL PURPOSES.
• Type of Device: COVER, MATTRESS (MEDICAL PURPOSES)
• Manufacturer (Section D): TRIDIEN
• MDR Report Key: 17537006
• MDR Text Key: 321043123
• Report Number: MW5143888
• Device Sequence Number: 1
• Product Code: FMW
• 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: 06/13/2018

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