MAUDE Adverse Event Report: CAREX E-Z BATH AND SHOWER SEAT WITH HANDLES

Model Number FGB66000 0000

Device Problems Crack (1135); Unstable (1667); Material Integrity Problem (2978)

Patient Problems Bruise/Contusion (1754); Fall (1848); Head Injury (1879)

Event Type  Injury  

Event Description

The end-user was in the shower, and the shower seat gave out on her; the end-user's daughter-in-law stated the chair cracked while her mother-in-law was sitting on its seat - this scared them very much.The leg of the chair only (one) gave out on her.She fell and hit her head on the toilet.She cannot get up on her own when she falls.She hit her head and her eye on the toilet, and received a knot on her forehead and a black eye from this fall.She had a nurse look at her, and she is fine.The event is reported as having occurred in an end-user's home, on a device that was used 7 times on a fiberglass surface.The snap buttons are reported as having been snapped in by the end-user's daughter (in-law) & all portions of the seat are reported as having been tightened and secured/check out by her daughter (in-law) as well.The device involved with this event was thrown away and cannot be returned.

• Brand Name: CAREX E-Z BATH AND SHOWER SEAT WITH HANDLES
• Type of Device: SHOWER SEAT
• MDR Report Key: 6377866
• MDR Text Key: 69091942
• Report Number: 3012316249-2017-00022
• 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
• Report Date: 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FGB66000 0000
• Device Catalogue Number: B660-00
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/03/2017
• Distributor Facility Aware Date: 02/06/2017
• Event Location: Home
• 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: 80 YR
• Patient Weight: 114