MAUDE Adverse Event Report: RAYES INC. (D/B/A SIZEWISE MANUFACTURING) / RAYE'S, INC DBA SIZEWISE MANUFACTURING MATTRESS, AIR FLOTATION, ALTERNA; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Little details.Hospital was visited by accreditation surveyor that happened to pull a chart of a patient that was on an sizewise alternate mattress replacement system.Incident reportedly occurred in (b)(6) 2022 but local staff were unaware and uninformed.Local personnel were made aware by facility staff by phone on 8/17/2023.

• Brand Name: MATTRESS, AIR FLOTATION, ALTERNA
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): RAYES INC. (D/B/A SIZEWISE MANUFACTURING) / RAYE'S, INC DBA SIZEWISE MANUFACTURING; hays KS 67601
• MDR Report Key: 17788393
• MDR Text Key: 324062957
• Report Number: MW5145979
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other