MAUDE Adverse Event Report: COMPASS HEALTH BRANDS CAREX; UNIVERSAL TRANSFER BENCH

Model Number	FGB17000 0000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Fall (1848)
Date of Event	05/27/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The end-user was a guest at a hotel and was taking a shower in the handicap accessible room when the leg of the shower chair broke, causing him to fall forward onto his nub leg.

• Brand Name: CAREX
• Common Device Name: UNIVERSAL TRANSFER BENCH
• Manufacturer (Section D): COMPASS HEALTH BRANDS; 6753 engle road; middleburg heights 44130
• MDR Report Key: 9086695
• Report Number: 3012316249-2019-00025
• Device Sequence Number: 16072884
• Product Code: ILS
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/19/2019

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
• Operator of Device: Lay User/Patient
• Device Model Number: FGB17000 0000
• Device Catalogue Number: B170-00
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other