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

Model Number	FCEQRSIDE
Health Effect - Clinical Code	Suture Abrasion (2497)
Date of Event	01/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the patient was being transferred by a nursing aide from the bed and the patient's left lower outer leg was scratched by a metal piece on the side rail of the bed resulting in a cut that was approximately 11 ½ x 4 cm.It was reported that the patient was sent to the emergency department and an unknown number of sutures were required.The director of nursing reported that the patient was treated at the emergency room and sent back to the facility with prophylactic antibiotics (keflex every 6 hours x 10 days) with no additional intervention required.As of this report the sample has not been returned to the manufacturer for evaluation.No additional information is available.Due to the reported incident, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the customer was transferring from the bed and cut their leg on the side rail requiring sutures.

• Brand Name: Medline
• Common Device Name: ALTERRA QUICK RELEASE SIDE RAILS
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• MDR Report Key: 9782314
• Report Number: 1417592-2020-00021
• Device Sequence Number: 16806838
• Product Code: FNL
• UDI-Device Identifier: 10884389104507
• UDI-Public: 10884389104507
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2020

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
• Operator of Device: Health Professional
• Device Model Number: FCEQRSIDE
• Device Catalogue Number: FCEQRSIDE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 03/03/2020
• 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: Required Intervention
• Patient Weight: 55