MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE; BAR,ASSIST,FLIP DOWN FOR FCE1232 BED

Model Number	FCE1232ABN
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	11/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported a patient was injured while working with two therapists on transfers into bed.Patient sustained an injury to her lower right leg that required medical attention.Email received by webster manor, with additional information in regards to this incident.Reporter states, incident occurred (b)(6) 2020 when (b)(6) female resident was "working with two therapists on transfers into bed when the patient stated "ouch" and reached down to her lower right leg." reporter states, "patient was noted to be bleeding and had a new open wound." reporter states a registered nurse was notified, first aid administered however, the leg continued to bleed and needed further attention.Reporter states, the patient's physician was contacted and the patient was transferred to webster emergency department (ed).Reporter states the patient was treated (wound was glued and steri-striped together) and the patient was released that day.Reporter states, "no prescriptions were indicated.The reporter states, "the wound is assessed every shift for signs and symptoms of infection." and states, "the patient is doing ok." pictures are available and have been requested for evaluation.Due to the reported incident, medical intervention 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 a patient was injured while working with two therapists on transfers into bed.Patient sustained an injury to her lower right leg that required medical attention.

• Brand Name: MEDLINE
• Common Device Name: BAR,ASSIST,FLIP DOWN FOR FCE1232 BED
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 10920025
• Report Number: 1417592-2020-00144
• Device Sequence Number: 16371248
• Product Code: FNJ
• UDI-Device Identifier: 40884389106427
• UDI-Public: 40884389106427
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/30/2020

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: FCE1232ABN
• Device Catalogue Number: FCE1232ABN
• Device Lot Number: 54119110001
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 11/30/2020
• 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 Age: 82 YR