MAUDE Adverse Event Report: COMPASS HEALTH BRANDS E-Z BATH & SHOWER SEAT WITH HANDLES

Model Number FGB66000 0000

Device Problems Collapse (1099); Material Integrity Problem (2978)

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

Event Type  malfunction  

Event Description

The shower seat's leg came unattached at the bottom of its seat, and it collapsed as the customer was sitting on it.No injuries were reported with this malfunction.

• Brand Name: E-Z BATH & 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: 5947201
• MDR Text Key: 54628352
• Report Number: 9681423-2016-00012
• 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: Other
• Type of Report: Initial
• Report Date: 09/13/2016

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: Not provided
• Initial Date FDA Received: 09/13/2016
• 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: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 127