MAUDE Adverse Event Report: GF HEALTH PRODUCTS, INC LUMEX; COMMODE

Catalog Number 6433A-2

Device Problems Loose or Intermittent Connection (1371); Device Slipped (1584)

Patient Problems Fall (1848); Injury (2348); Tooth Fracture (2428)

Event Date 06/23/2015

Event Type  malfunction  

Event Description

Patient put her weight on the arms of one of our portable drop arm commodes and one of the drop arms gave way.She fell to the floor hit her mouth and damaged some of her teeth.After the incident it was noticed that the drop arm that gave way wobbled about 1/2 an inch compared to a new commode that did not wobble at all.It was also noticed of the commode involved in the incident that the drop arm locking mechanism would release when pressure was put on the vertical side of the drop arm.

• Brand Name: LUMEX
• Type of Device: COMMODE
• Manufacturer (Section D): GF HEALTH PRODUCTS, INC; 2935 northeast parkway; atlanta GA 30360
• MDR Report Key: 4934884
• MDR Text Key: 6009854
• Report Number: 4934884
• Device Sequence Number: 1
• Product Code: INB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 06/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: 6433A-2
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/29/2015
• Event Location: Hospital
• Date Report to Manufacturer: 07/23/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1