MAUDE Adverse Event Report: POPULAR PLASTICS IVC I-FIT SHOWER CHAIR W/BACK 9153641763; ADAPTOR, HYGIENE

Model Number 9781

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The legs aren't locking into socket/off center.

• Brand Name: IVC I-FIT SHOWER CHAIR W/BACK 9153641763
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): POPULAR PLASTICS; guangzhou & donggua ; CH
• MDR Report Key: 4489829
• MDR Text Key: 18925736
• Report Number: 1531186-2015-00839
• 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: 02/05/2015,01/30/2015

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9781
• 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: 01/30/2015
• 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