MAUDE Adverse Event Report: LIFESTYLE MOBILITY AIDS LIFESTYLE COMMODE

Model Number B3500F

Device Problems Collapse (1099); Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 07/22/2016

Event Type  Injury  

Event Description

Patient reported that the commode collapsed while she was using it which caused her hip to dislocate.

• Brand Name: LIFESTYLE COMMODE
• Type of Device: LIFESTYLE COMMODE
• Manufacturer (Section D): LIFESTYLE MOBILITY AIDS; seminole FL 33775
• MDR Report Key: 5852969
• MDR Text Key: 51473354
• Report Number: MW5063874
• Device Sequence Number: 1
• Product Code: INB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: B3500F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 65 YR
• Patient Weight: 99