MAUDE Adverse Event Report: DRIVE MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem Pressure Sores (2326)

Event Type  Injury  

Event Description

Per customer states she has an overlay manress from dove that is hard and 1s causmg bed sores no serial number available and no additional information provided 232451.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): DRIVE
• MDR Report Key: 17528887
• MDR Text Key: 321143530
• Report Number: MW5135816
• 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: 02/04/2020

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