MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.; COMMODE

Model Number MDS89664XW

Device Problem Device Slipped (1584)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 05/17/2014

Event Type  Injury  

Event Description

The patient was getting out of bed to use the bedside commode.To this point the patient had been doing so independently.According to the report, the patient put her weight on the commode and it gave way causing the patient to fall.Later the x-ray revealed a fracture of her t-12 thoracic vertebrae.A consult with neuro surgery stated the patient could be discharged with the brace and if that failed they would recommend vertebroplasty.

• Type of Device: COMMODE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline pl; mundelein IL 60060
• MDR Report Key: 4168657
• MDR Text Key: 5021252
• Report Number: 4168657
• Device Sequence Number: 1
• Product Code: ILS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 10/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: MDS89664XW
• Device Catalogue Number: MDS89664XW
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/02/2014
• Event Location: Hospital
• Date Report to Manufacturer: 10/14/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 77 YR