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

Model Number FGB65100 0000

Device Problem Unstable (1667)

Patient Problem Fall (1848)

Event Type  Injury  

Event Description

The end-user fell again (first fall occurred on a different shower seat, and did not result in a "serious injury"), except this time, it was the left side of the bath & shower seat that gave out.The user stated that the eyelets are separating from the seat themselves; the user stated that because the legs are crossed, the weight is putting tension on the eyelets, which is pulling them away from the seat itself.When the user fell, he smacked his body and face against the shower wall because he has paralysis on the side he fell on.He has had a stroke and cannot use that side fully.He had some redness on his face, but did not seek medical attention.The event is reported as having occurred on a ceramic surface, and regular/weekly maintenance is also reported as having occurred on the device.The device involved with this event was returned to compass health brands for further evaluation on 5/1/2017.The returned device was found to have its center/middle metal anchor slightly extruded.The frame/leg tubing was not found to be bent upon return.

• Brand Name: CAREX ADJUSTABLE BATH & SHOWER SEAT WITH BACK
• Type of Device: SHOWER SEAT
• Manufacturer (Section D): NINGBO SOUTH INDUSTRIAL CO., LTD.; fengcheng village; jishigang town; yinzhou, 31517 1; CH 315171
• MDR Report Key: 6558665
• MDR Text Key: 74889189
• Report Number: 3012316249-2017-00048
• 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: Other
• Type of Report: Initial
• Report Date: 05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2017
• 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: 05/10/2017
• Distributor Facility Aware Date: 04/12/2017
• Event Location: Home
• Date Report to Manufacturer: 05/10/2017
• 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: 39 YR
• Patient Weight: 122