MAUDE Adverse Event Report: INVACARE CORPORATION (TW) ALL-IN-ONE-ALUMINUM COMMODE 4 PER CARTON 9153637754; ADAPTOR, HYGIENE

Model Number 9650

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Fall (1848)

Event Date 03/03/2019

Event Type  malfunction  

Event Description

While pt was sitting on bedside commode, metal bar on bottom frame of bedside commode broke off, causing pt to fall through.No injury to patient.Pt weight and use appropriate for equipment.

• Brand Name: ALL-IN-ONE-ALUMINUM COMMODE 4 PER CARTON 9153637754
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): INVACARE CORPORATION (TW); 39400 taylor pkwy; north ridgeville OH 44035
• MDR Report Key: 8439214
• MDR Text Key: 139418559
• Report Number: 8439214
• 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: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 9650
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/19/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 31755 DA