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

Model Number FGB65100 0000

Device Problem Device Slipped (1584)

Patient Problems Pain (1994); Injury (2348)

Event Date 07/18/2017

Event Type  Injury  

Event Description

The end-user was on the bath & shower seat in the shower, and the seat went to the right and splayed out.The plastic on the seat caved in the middle, and the legs went out on the end-user.The end-user hit the ground after five back surgeries.The end-user saw his doctor, and has a lump on his back from where he hit the floor - he will return to the doctor on friday, as he has a lot of pain in his back.The event is reported as having occurred on a fiberglass surface.Regular weekly maintenance is reported as having occurred on the device.

Event Description

The device involved with this event was returned to compass health brands on 8/15/2017 & inspected on 8/16/2017.The customer's complaint could be confirmed from a review of the returned device.The left rear leg (if looking at device while standing in front of it) was found to be bent inwards side to side, and outwards from front to back - this resulted in the chair leaning to the left.The metal anchors in the unit are still in place, and are not pulled out of the plastic at all; all of the hand screws are slightly bent on the unit - the whole unit is slightly bent, and not easily matching up.The plastic seat also has a crease in its middle on the back lip.Again, the customer's complaint could be confirmed from a review of the returned device.

• 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: 6790216
• MDR Text Key: 82564549
• Report Number: 3012316249-2017-00096
• 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,Followup
• Report Date: 09/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/12/2017
• Distributor Facility Aware Date: 07/18/2017
• Event Location: Home
• Date Report to Manufacturer: 09/12/2017
• 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: 73 YR
• Patient Weight: 115