MAUDE Adverse Event Report: JOERNS HEALTHCARE ASSIST DEVICE; PATIENT BED RAIL

Model Number F026AL

Device Problem Material Separation (1562)

Patient Problem Laceration(s) (1946)

Event Date 04/04/2017

Event Type  Injury  

Event Description

It was reported to the manufacturer by the end user, per the end user the cna was assisting the resident into the back into bed from the wheelchair.The cna was holding the resident under the arm and assisting the resident with a quarter turn to be able to set the resident onto the bed.As the resident was turning and being ready to set down was when the laceration occurred.As the resident was set down on the bed, she told the cna that something pinched her.The cna looked and saw the laceration and proceeded to call for assistance and 911 was dialed at that time.The nursing applied a dressing until the paramedics arrived.The resident was transported to the hospital and received 30 stitches to the right shin.Complaint (b)(4) were entered into our system to have the assist rail returned to joerns for investigation.As of this writing, the assist rail has not been returned.

• Brand Name: ASSIST DEVICE
• Type of Device: PATIENT BED RAIL
• Manufacturer (Section D): JOERNS HEALTHCARE; avenida pedro hinojosa no.26; ciudad industrial; matamoros, tamaulipas 87499 ; MX 87499
• Manufacturer (Section G): JOERNS HEALTHCARE; avenida pedro hinojosa no.26; ciudad industrial; matamoros, tamaulipas 87499 ; MX 87499
• Manufacturer Contact: felicia banks ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 6500148
• MDR Text Key: 73022613
• Report Number: 3009402404-2017-00021
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/18/2017

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?: No
• Device Operator: Nursing Assistant
• Device Model Number: F026AL
• Device Catalogue Number: F026AL
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2017
• Initial Date FDA Received: 04/18/2017
• Was Device Evaluated by Manufacturer?: No
• 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