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

Model Number 6895

Device Problem Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Customer states to dealer that both of the front casters lock up when moving.Proof of purchase is needed from consumer for warranty coverage.Dealer to contact customer.

• 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: 4327355
• MDR Text Key: 5214865
• Report Number: 1531186-2014-06239
• 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: 12/11/2014,11/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2014
• 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: 12/11/2014
• Distributor Facility Aware Date: 11/21/2014
• Device Age: 41 MO
• Date Report to Manufacturer: 12/11/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other