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

Model Number FGB65100 0000

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Bruise/Contusion (1754); Fall (1848); Bone Fracture(s) (1870)

Event Type  Injury  

Event Description

The shower chair's left front leg gave out - the leg, left front side of the chair, nothing looked bent at first, but as soon as the customer turned the water off, she heard a thump, and her mother-in-law fell on the floor.The user did go to the doctor, but not until days later.The user hurt her hip, which had a bruise - she was taken to a hospital, where she found her tailbone was cracked.The hospital did x-rays, showing she had a small crack.The event is reported as having occurred on a non-skid plastic.The user is reported as having been supervised or assisted at the time the malfunction had occurred.Regular weekly maintenance is not reported as having occurred on this device, as the customer had not had the device that long (device is reported as having been in circulation 1 1/2 months).The device involved with this event was returned to (b)(4) and evaluated on 7/10/2017.The returned device was found to have number 1 & 2 metal anchors detached - these metal anchors are what hold the legs of the device to its seat, by the screw going into the threaded metal anchor.None of the legs appeared to have been bent while the inspection was conducted.

• 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: 6720078
• MDR Text Key: 80252567
• Report Number: 3012316249-2017-00083
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• 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?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/17/2017
• Distributor Facility Aware Date: 06/23/2017
• Event Location: Home
• Date Report to Manufacturer: 07/17/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 87 YR
• Patient Weight: 59