MAUDE Adverse Event Report: DRIVE MEDICAL CANADA, INC. COMMODE, FOLDING, WITH DEEP SEAT; ADAPTOR, HYGIENE

Model Number 11148N-1

Device Problems Material Integrity Problem (2978); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 08/04/2021

Event Type  malfunction  

Event Description

The front left leg of the bedside commode (bsc)is bent in.It should have better integrity and should not have bent like this.

• Brand Name: COMMODE, FOLDING, WITH DEEP SEAT
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): DRIVE MEDICAL CANADA, INC.; 99 seaview blvd; port washington NY 11050
• MDR Report Key: 12376887
• MDR Text Key: 268448917
• Report Number: 12376887
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/17/2021

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: No Information
• Device Model Number: 11148N-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/17/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25915 DA