MAUDE Adverse Event Report: COMPASS HEALTH BRANDS 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 09/18/2016

Event Type  malfunction  

Manufacturer Narrative

Device return not anticipated.

Event Description

The consumer has a shower seat - the point where the leg meets the seat is cracked.When the husband of the end-user picked up the seat, the legs had fallen out.The user is not reported as having fallen/received an injury due to this malfunction.The seat is reported as having been used on a fiberglass surface, and is reported as having not been sat on at the time the event had occurred.One of its feet is also reported as having a cut in it.The shower seat is otherwise reported as having been owned, and used for 6 months.

• Brand Name: E-Z BATH AND SHOWER SEAT WITH HANDLES
• Type of Device: SHOWER SEAT
• Manufacturer (Section D): COMPASS HEALTH BRANDS; 11 morris dr.; suite 111; dartmouth, nova scotia B3B 1 M2; CA B3B 1M2
• Manufacturer (Section G): COMPASS HEALTH BRANDS; 11 morris dr.; suite 111; dartmouth, nova scotia B3B 1 M2; CA B3B 1M2
• Manufacturer Contact: kaycee nichols ; 6753 engle road; n/a; middleburg heights, OH 44130 ; 8009471728
• MDR Report Key: 6052229
• MDR Text Key: 58244846
• Report Number: 9681423-2016-00016
• 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
• Report Date: 10/24/2016

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?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/29/2016
• Initial Date FDA Received: 10/24/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 127