MAUDE Adverse Event Report: LERADO GLOBAL FOLDING COMMODE 9153647607; ADAPTOR, HYGIENE

Model Number 9830-4

Device Problems Unstable (1667); Out-Of-Box Failure (2311)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2014

Event Type  malfunction  

Event Description

It has been reported that the end user is missing one snap button from the back support on a 9830-4 commode out of the box, causing it to slide down.

• Brand Name: FOLDING COMMODE 9153647607
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): LERADO GLOBAL; no. 26-54b,; 7andar h7 edif. centro com; macau ; CH
• MDR Report Key: 4353058
• MDR Text Key: 5223793
• Report Number: 1531186-2014-06734
• 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: Distributor
• Source Type: Invalid Data
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/22/2014,11/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9830-4
• 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: 12/22/2014
• Distributor Facility Aware Date: 11/10/2014
• Device Age: 2 YR
• Date Report to Manufacturer: 12/22/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other