MAUDE Adverse Event Report: N/A E-Z BATH AND SHOWER SEAT WITH HANDLES

Model Number FGB66000 0000

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/22/2016

Event Type  malfunction  

Event Description

The consumer was taking a shower, and the legs on the shower seat buckled, causing it to tip over.The end-user was not injured.The device is reported as having been used on a ceramic surface, with all four legs touching the floor at the time the incident had occurred.

Event Description

The device was returned to the manufacturer, (b)(4), on 9/9/2016.The original item number provided in the initial complaint was fgb67100 0000, universal bath bench w/back.The item number of the returned device was fgb66000 0000 e-z bath & shower seat with handles.The malfunction reported by the customer/end-user in the initial complaint was that the fgb67100 0000's legs had buckled, causing the device to tip over.The returned fgb66000 0000 was found to have its front slot where it leg slides into place as cracked - this allowed the leg to slightly move, and compromise its integrity.

• Brand Name: E-Z BATH AND SHOWER SEAT WITH HANDLES
• Type of Device: BATH AND SHOWER SEAT
• Manufacturer (Section D): N/A; n/a; n/a; n/a, n/a B3B 1 M2; CA B3B 1M2
• Manufacturer (Section G): N/A; n/a; n/a; n/a, n/a B3B 1 M2; CA B3B 1M2
• Manufacturer Contact: n/a n/a ; n/a; n/a; n/a, OH 44130 ; 8009471728
• MDR Report Key: 5950986
• MDR Text Key: 54761286
• Report Number: 9681423-2016-00014
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 10/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/25/2016
• Initial Date FDA Received: 09/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 127