MAUDE Adverse Event Report: PRIMA TECH BED; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number RASAF3000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fall (1848)

Event Date 05/24/2021

Event Type  Injury  

Event Description

She was not properly placed back on the center of the bed and moved closer to the side and rolled off skin tear - just needed first aid skin tear - just needed first aid.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BED
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): PRIMA TECH
• MDR Report Key: 17529736
• MDR Text Key: 321099828
• Report Number: MW5136660
• Device Sequence Number: 1
• Product Code: FNL
• 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: 06/25/2021

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
• Device Model Number: RASAF3000
• Patient Sequence Number: 1