MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE; RAIL,SIDE,HEAD SECTION,SOFT TOUCH

Model Number	FCE1232RSRN
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	05/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the patient was being transferred from the wheelchair to the bed and when the staff attempted to transfer the patient the rail of the bed caught on the patients left lower leg resulting in a 14 cm long laceration.The patient was transferred to the hospital for evaluation and treatment.At the hospital the laceration was determined to require an unreported number of sutures.The sutures were put in place, the patient was placed on overnight observation and also started on antibiotic therapy.The patient was released back to the facility the next day.Prior to the incident occurring the patient was scheduled to be transferred to a hospice facility and the day after the patient returned from the hospital the client was transferred to the hospice facility as planned.No additional patient details are available.A photo depicting the reported side rail was provided to the manufacturer and only a visual review could be conducted.A functional or dimensional inspection could not be executed via a photo.The customer is stating that the rails were down when they tried to move the patient.During the moving motion the patient suffered a 14 cm laceration.At this time the customer's complaint cannot be confirmed.Should the customer send back the physical sample, a full investigation will be conducted.A definitive root cause for the reported issue could not be determined at this time.There is no additional information 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 patient was being transferred from the wheelchair to the bed and when the staff attempted to transfer the patient the rail of the bed caught on the patients left lower leg resulting in a 14 cm long laceration requiring sutures.

• Brand Name: MEDLINE
• Common Device Name: RAIL,SIDE,HEAD SECTION,SOFT TOUCH
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 12104062
• Report Number: 1417592-2021-00113
• Device Sequence Number: 4202992
• Product Code: FNJ
• UDI-Device Identifier: 10080196313877
• UDI-Public: 10080196313877
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/01/2021

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 Model Number: FCE1232RSRN
• Device Catalogue Number: FCE1232RSRN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 07/01/2021
• 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; Required Intervention
• Patient Weight: 57