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

Model Number FCE1232ABN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 11/09/2020

Event Type  malfunction  

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 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
• Type of Device: BAR,ASSIST,FLIP DOWN FOR FCE1232 BED
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: teresa maynard ; three lakes drive; northfield, IL 60093-2753 ; 2249311514
• MDR Report Key: 10920025
• MDR Text Key: 220629867
• Report Number: 1417592-2020-00144
• Device Sequence Number: 1
• Product Code: FNJ
• UDI-Device Identifier: 40884389106427
• UDI-Public: 40884389106427
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FCE1232ABN
• Device Catalogue Number: FCE1232ABN
• Device Lot Number: 54119110001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/16/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR