MAUDE Adverse Event Report: NINGBO SOUTH INDUSTRIAL CO., LTD. CAREX; ADJUSTABLE BATH & SHOWER SEAT W/BACK

Model Number FGB65100 0000

Device Problem Unstable (1667)

Patient Problem Fall (1848)

Event Type  Injury  

Event Description

The leg gave out on the bath & shower seat, and the user fell backwards, hitting his head.The user did not go to the hospital.

• Brand Name: CAREX
• Type of Device: ADJUSTABLE BATH & SHOWER SEAT W/BACK
• Manufacturer (Section D): NINGBO SOUTH INDUSTRIAL CO., LTD.; fengcheng village; jishigang town; yinzhou, 31517 1; CH 315171
• MDR Report Key: 6773747
• MDR Text Key: 82051064
• Report Number: 3012316249-2017-00093
• 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
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FGB65100 0000
• Device Catalogue Number: B651-00
• 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: 08/08/2017
• Distributor Facility Aware Date: 07/10/2017
• Date Report to Manufacturer: 08/08/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other