MAUDE Adverse Event Report: AID-PRO HEALTHCARE CO., LTD CAREX; TRANSFER BENCH

Model Number FGB15577 0000

Device Problem Break (1069)

Patient Problems Contusion (1787); Fall (1848); Head Injury (1879)

Event Date 09/29/2019

Event Type  Injury  

Event Description

The end user was showering and the tip of the left rear tip snapped out of place causing the bench to tip over and the user fell and hit the side of the tub.Tried to use the handle of the bench to regain her balance and then the bench tipped and she fell out of the tub and hit the floor.Head and knees are bruised, has rug burn from trying to get up, was knocked out from the fall.Sister was upstairs doing laundry and heard the fall and went in to help her and help her get up.Has a shunt in her head that she feels may be dented and is going to the doctor as soon as possible to get it checked out.

• Brand Name: CAREX
• Type of Device: TRANSFER BENCH
• Manufacturer (Section D): AID-PRO HEALTHCARE CO., LTD; no. 58 yu long 3 road; dong sheng town; zhong shan city guangdong, ; CH
• MDR Report Key: 9221692
• MDR Text Key: 169729209
• Report Number: 3012316249-2019-00036
• Device Sequence Number: 1
• Product Code: KTC
• 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: 10/22/2019

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
• Device Operator: Lay User/Patient
• Device Model Number: FGB15577 0000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/22/2019
• Distributor Facility Aware Date: 09/30/2019
• Event Location: Home
• Date Report to Manufacturer: 10/22/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Weight: 36