MAUDE Adverse Event Report: HEALTH PLUS HEALTH & MEDICAL DAILY ACTIVITY ASSIST DEVICES; 890.5050

Model Number 6500-BHD

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  No Answer Provided  

Event Description

Per end-user, alleges the rubber tips on a 6500-bhd commode need replaced.

• Brand Name: DAILY ACTIVITY ASSIST DEVICES
• Type of Device: 890.5050
• Manufacturer (Section D): HEALTH PLUS HEALTH & MEDICAL; 24310 moulton pkwy; unit g; laguna woods CA 92653
• MDR Report Key: 4126866
• MDR Text Key: 4919820
• Report Number: 1531186-2014-04539
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/29/2014,09/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6500-BHD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2014
• Distributor Facility Aware Date: 09/09/2014
• Date Report to Manufacturer: 09/29/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other