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); Crack (1135)

Patient Problems Fall (1848); Skin Tears (2516)

Event Type  Injury  

Event Description

Dealer stated that the left front caster wheel on a 6895 shower commode chair fell off causing the user to fall out of the chair.End user had to call 911 to help him up, he sustained a cut on his arm.Dealer stated that the footrest is cracked and an issue with the padded seat cushion.

• 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: 4489499
• MDR Text Key: 5329018
• Report Number: 1531186-2015-00819
• 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: 02/05/2015,02/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2015
• Is this an Adverse Event Report?: Yes
• 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: 02/05/2015
• Distributor Facility Aware Date: 02/02/2015
• Device Age: 3 YR
• Date Report to Manufacturer: 02/05/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other