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

Model Number FGB65100 0000

Device Problems Collapse (1099); Material Deformation (2976)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Laceration(s) (1946)

Event Date 08/09/2019

Event Type  Injury  

Event Description

The family was vacationing in (b)(6).The subject was showering.The back right leg of the shower seat in question lost it's shape and the individual using the chair landed on his back on the floor between the toilet and shower.Paramedics were called since the subject has limited mobility and professional help is necessary.The doctor determined that one of his fingers had two or three fractures.It was splinted and iced.His wife took him to an orthopedic specialist.The end-user received outpatient surgery, straightening the finger and securing it with pins.The surgeon indicated that without the surgery the end users hand would have been deformed.The photo of the chair shows the rear right leg (if sitting in the chair) has bent backwards, pointing backwards away from the chair.The chair is owned by the father-in-law.

• Brand Name: CAREX
• Type of Device: ADJUSTABLE BATH & SHOWER SEAT W/BACK
• Manufacturer (Section D): NINGBO SOUTH INDUSTRIAL CO., LTD; fengcheng village, jishigang t; yinzhou; ningbo zhejiang, 31517 1; CH 315171
• MDR Report Key: 9161175
• MDR Text Key: 161783785
• Report Number: 3012316249-2019-00030
• 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: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• 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: 10/07/2019
• Distributor Facility Aware Date: 09/16/2019
• Event Location: Other
• Date Report to Manufacturer: 10/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Weight: 104