MAUDE Adverse Event Report: COMPASS HEALTH BRANDS CAREX; PORTABLE SHOWER BENCH

Model Number FGB21701 0000

Device Problem Break (1069)

Patient Problems Loss of Range of Motion (2032); Injury (2348)

Event Date 02/20/2018

Event Type  Injury  

Event Description

The end-user states that one of the screws broke causing them to fall backwards when the board lost the adjustment provided by the plastic screw.The end-user tore their right shoulder rotator cuff by hitting their right elbow.

• Brand Name: CAREX
• Type of Device: PORTABLE SHOWER BENCH
• Manufacturer (Section D): COMPASS HEALTH BRANDS; 6753 engle road; middleburg heights 44130
• Manufacturer (Section G): COMPASS HEALTH BRANDS; 6753 engle road; middleburg heights 44130
• Manufacturer Contact: cynthia toney ; 6753 engle road; middleburg heights 44130 ; 4402682110
• MDR Report Key: 7459309
• MDR Text Key: 106587718
• Report Number: 3012316249-2018-00023
• 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: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FGB21701 0000
• Device Catalogue Number: B217-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other