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

Model Number FGB65100 0000

Device Problems Break (1069); Collapse (1099); Material Separation (1562)

Patient Problem Injury (2348)

Event Date 03/15/2019

Event Type  Injury  

Event Description

Received attorney letter stating "consumer sustained devastating personal injuries sustained by a faulty shower seat/chair that broke and collapsed".The right (sitting) rear leg detached, u bar cracked through pre-drilled hole for the hand screw.

• Brand Name: CAREX
• Type of Device: ADJUSTABLE BATH & SHOWER SEAT WITH BACK
• Manufacturer (Section D): NINGBO SOUTH INDUSTRIAL CO., LTD.; fengcheng village, jishigang t; yinzhou; ningbo zhejiang, 31517 1; CH 315171
• MDR Report Key: 8840860
• MDR Text Key: 152627741
• Report Number: 3012316249-2019-00017
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/30/2019
• Distributor Facility Aware Date: 07/09/2019
• Date Report to Manufacturer: 07/30/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other