MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; ALTERRA QUICK RELEASE SIDE RAILS

Catalog Number	FCEQRSIDE
Health Effect - Clinical Code	Skull Fracture (2077)
Date of Event	12/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported from the facility administrator that a patient in a long term care unit was transferring themselves from the bed and when the patient was getting themselves up they grabbed onto the side rail and the side rail came off of the bed and the patient fell onto the floor.The administrator reported that the fall was unwitnessed; however when the patient fell he sustained a skull fracture and was transferred to a hospital neuro unit.According to the administrator the patient is still at the hospital and is doing fine.Despite multiple good faith efforts to obtain additional information, the administrator was unable or unwilling to provide further patient or incident details to the manufacturer.The actual device involved in the incident was evaluated on-site and was found to have a lack of maintenance.No additional information is available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that a patient was using the side rail to get up and the side rail came off which may have resulted in a patient fall.

• Common Device Name: ALTERRA QUICK RELEASE SIDE RAILS
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8286888
• Report Number: 1417592-2019-00001
• Device Sequence Number: 16641998
• Product Code: FNL
• UDI-Device Identifier: 10884389104507
• UDI-Public: 10884389104507
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/29/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: FCEQRSIDE
• Device Lot Number: 54118060001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 01/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 71 YR
• Patient Weight: 82