MAUDE Adverse Event Report: CAREX; TRANSFER BENCH

Model Number FGB15300 0000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fall (1848)

Event Type  Injury  

Event Description

The transfer bench was purchased about 6 months ago.The user fell 2-3 months ago when the right back leg's pin bent.It threw him backwards in the tub.He hit his shoulder and his back.He wasn't going to say anything, but he still isn't able to raise his right arm up above his head.He doesn't remember who all he has seen about this injury, but he said that he went to a chiropractor who did an x-ray on his arm.The chiropractor didn't know what was wrong.As of (b)(6) 2019 (when serious injury was identified), he's also gone to a clinic, and they told him that his rotator cup is messed up on the left side.They said that there is a strong possibility that the fall caused the problem with his rotator cuff.As of (b)(6) 2019, he is now saying that it is the left arm that he can't lift up above his head - the user was asked to clarify, as he originally reported that it was his right, but he said he injured the left rotator cuff when he fell.He needs to have his knee fixed before he can have his shoulder fixed.His knee wasn't injured as a result of this fall (knee surgery is required, as he has bone on bone).The user insisted that one of the legs on the transfer bench was bent.The device involved with this event was returned to compass health brands on 11/8/2018.The returned unit was found to have a heavy residue of a mildew-like substance.The metal screws on the returned unit were found to be heavily rusted.One c-clip was found to be missing; the backrest was found to have been unscrewed & detached by the user.The returned unit was not bent & no stress points were discovered.Overall, the customer's complaint was unable to be duplicated from a review of the returned device.

• Brand Name: CAREX
• Type of Device: TRANSFER BENCH
• MDR Report Key: 8375789
• MDR Text Key: 137318755
• Report Number: 3012316249-2019-00007
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FGB15300 0000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/27/2019
• Distributor Facility Aware Date: 09/21/2018
• Event Location: Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 67 YR
• Patient Weight: 133