MAUDE Adverse Event Report: UNKNOWN MOBILE SHOWER/COMMODE 9153617968; ADAPTOR, HYGIENE

Model Number 6358

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The dealer states he has 5 shower chairs that have had the back upholstery rip at the top on the seams.These are being used in a nursing facility for numerous patients.No other information is available.

• Brand Name: MOBILE SHOWER/COMMODE 9153617968
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): UNKNOWN; OH
• MDR Report Key: 4444164
• MDR Text Key: 5309870
• Report Number: 1531186-2015-00503
• 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: 01/22/2015,01/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6358
• 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: 01/22/2015
• Distributor Facility Aware Date: 01/15/2015
• Date Report to Manufacturer: 01/22/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other