MAUDE Adverse Event Report: RAYE'S, INC DBA SIZEWISE MANUFACTURING SIZEWISE MATTRESS; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/07/2022

Event Type  malfunction  

Event Description

Pt with known hapi upon assessment low airloss mattress not functioning.Called to have mattress replaced.Unknown how long mattress was not working.Fda safety report id# (b)(4).

• Brand Name: SIZEWISE MATTRESS
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): RAYE'S, INC DBA SIZEWISE MANUFACTURING
• MDR Report Key: 15130215
• MDR Text Key: 297038199
• Report Number: MW5111178
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Male