MAUDE Adverse Event Report: RAISE MEDICAL INDUSTRIES, INC. CAREX; BEDSIDE RAIL

Model Number FGP57000 0000

Device Problems Bent (1059); Break (1069); Crack (1135)

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

Event Type  Injury  

Event Description

The user had this bedside rail since (b)(6) of 2016 - he fell out of bed (was laying in bed and rolled out), and bent the frame of the rail.The user bent it back, but then fell a second time a few nights later, and the frame completely broke.The user hit his head when he fell, and his wife iced it to keep the swelling down - he did not seek medical treatment.The device involved with this event was returned to compass health brands and evaluated on 8/15/2017 - the unit was found to have the part of its frame that goes in between the bed and the box spring bent/cracked, which resulted in the unit to rest at an angle.The crack happened right next to the weld.The customer's complaint could be confirmed from a review of the returned device.

• Brand Name: CAREX
• Type of Device: BEDSIDE RAIL
• Manufacturer (Section D): RAISE MEDICAL INDUSTRIES, INC.; phase 1, jiangli north road,; nansha industrial village; foshan city, guangdong 52821 6; CH 528216
• MDR Report Key: 6843845
• MDR Text Key: 84934570
• Report Number: 3012316249-2017-00110
• Device Sequence Number: 1
• Product Code: LLI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/05/2017

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: FGP57000 0000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/05/2017
• Distributor Facility Aware Date: 08/09/2017
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/05/2017
• 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: 72 YR
• Patient Weight: 109