MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - NORTHFIELD KNOCKDOWN BEDSIDE COMMODE; ATTACHMENT, COMMODE, WHEELCHAIR

Catalog Number MDS89664KD

Device Problems Collapse (1099); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 01/28/2022

Event Type  malfunction  

Event Description

Patient was on the commode chair and the right back leg bent and gave out, the commode subsequently collapsed.Equipment has weight limit of 350#.Patient weighs (b)(6).Unsure why bsc failed the way it did?.Fda safety report id # (b)(4).

• Brand Name: KNOCKDOWN BEDSIDE COMMODE
• Type of Device: ATTACHMENT, COMMODE, WHEELCHAIR
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NORTHFIELD
• MDR Report Key: 13472577
• MDR Text Key: 285323637
• Report Number: MW5107236
• Device Sequence Number: 1
• Product Code: INB
• 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: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MDS89664KD
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic