MAUDE Adverse Event Report: COMPASS HEALTH BRANDS FGB66000 0000; SHOWER SEAT

Model Number FGB66000 0000

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

Patient Problem Fall (1848)

Event Date 10/11/2016

Event Type  Injury  

Manufacturer Narrative

Device return anticipated.

Event Description

The patient slipped in the shower when attempting to stand, and the seat broke on the shower seat at the left front leg socket.A fall resulted from the slip, and a 911 call for medical assistance was required.

• Brand Name: FGB66000 0000
• 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: 6078560
• MDR Text Key: 59170519
• Report Number: 9681423-2016-00018
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 11/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Initial Date Manufacturer Received: 10/11/2016
• Initial Date FDA Received: 11/04/2016
• 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; Required Intervention