MAUDE Adverse Event Report: JOERNS HEALTHCARE HALF LENGTH ASSIST RAIL

Model Number F17TMAL

Device Problem Misassembled (1398)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 10/19/2014

Event Type  Injury  

Event Description

It was reported to the manufacturer by the facility ((b)(6)), per the facility the cna rolled the resident to her left side to provide care.The resident was holding onto the rail so she didn't roll back.The rail came off the bed.The resident and rail fell to the floor.The resident landed on top of the rail.X-rays were performed on (b)(6) 2014 on the resident's whole left side of the body.The x-rays were performed at the facility.On (b)(6) 2014, another x-ray of the resident's left foot/ankle were taken and the resident has two broken toes.(b)(4) were entered into our system to retrieve the rail for eval in (b)(6).The rail was received at the (b)(6) on (b)(6) 2014, but the installation hardware was not returned with the rail.During the investigation, it was determined through photographs taken at the facility that the incorrect installation hardware was used.The half length rail should be attached with a bolt and nut, but the rails involved in the incident were actually attached with a pin.

• Brand Name: HALF LENGTH ASSIST RAIL
• Type of Device: HALF LENGTH ASSIST RAIL
• Manufacturer (Section D): JOERNS HEALTHCARE; stevens point WI
• Manufacturer Contact: felicia banks ; 2100 design rd; arlington, TX 76014
• MDR Report Key: 4254549
• MDR Text Key: 5046381
• Report Number: 3009402404-2014-00021
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: F17TMAL
• Device Catalogue Number: F17TMAL
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/27/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/31/2014
• Distributor Facility Aware Date: 10/19/2014
• Event Location: Nursing Home
• Date Report to Manufacturer: 10/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 75 YR
• Patient Weight: 118