MAUDE Adverse Event Report: DRIVE MEDICAL CANADA, INC. MATTRESS, FLOTATION THERAPY, NON-POWERED

Model Number 14030XP

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 10/28/2022

Event Type  Injury  

Event Description

Item was not used for eua purposes.Fda safety report id #(b)(4).

• Brand Name: MATTRESS, FLOTATION THERAPY, NON-POWERED
• Type of Device: MATTRESS, FLOTATION THERAPY, NON-POWERED
• Manufacturer (Section D): DRIVE MEDICAL CANADA, INC.
• MDR Report Key: 15754749
• MDR Text Key: 303392066
• Report Number: MW5113149
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/03/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 14030XP
• Device Catalogue Number: 876678
• Device Lot Number: Q3-032
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 137 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White