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

Device Problem Device Fell (4014)

Patient Problem Fall (1848)

Event Date 05/21/2019

Event Type  malfunction  

Event Description

Patient was getting up from the bedside commode and sat back down.The bedside commode's side arms, which hold up the pan of the commode, fell off the commode's frame.Staff was at the patient's side to support patient and assisted patient to the bed.

• Brand Name: GUARDIAN
• Type of Device: ATTACHMENT, COMMODE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8726980
• MDR Text Key: 148970386
• Report Number: 8726980
• Device Sequence Number: 1
• Product Code: INB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/12/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25550 DA
• Patient Weight: 73