MAUDE Adverse Event Report: CAREMED ULTRACARE; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number ULTRACARE APL/CU CAREMED ULTRACARE APL

Device Problem Insufficient Information (3190)

Patient Problem Fall (1848)

Event Date 05/28/2018

Event Type  Injury  

Event Description

Patient fall.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ULTRACARE
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): CAREMED
• MDR Report Key: 17533594
• MDR Text Key: 321151404
• Report Number: MW5140498
• 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: 06/21/2018

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: ULTRACARE APL/CU CAREMED ULTRACARE APL
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1