MAUDE Adverse Event Report: KENSTONE METAL SHWR COMMODE 23 IN TIRES 18 INW 9153640949; ADAPTOR, HYGIENE

Model Number 6895

Device Problems Detachment Of Device Component (1104); Unstable (1667)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Customer alleges that the front stem bearings are gone on the left side.

• Brand Name: SHWR COMMODE 23 IN TIRES 18 INW 9153640949
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): KENSTONE METAL; kunshan ; CH
• MDR Report Key: 4423534
• MDR Text Key: 5276686
• Report Number: 1531186-2015-00285
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 01/14/2015,01/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6895
• 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: 01/14/2015
• Distributor Facility Aware Date: 01/05/2015
• Device Age: 11 MO
• Date Report to Manufacturer: 01/14/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/15/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other