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U.S. Department of Health and Human Services

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

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MEDLINE INDUSTRIES INC. MEDLINE BAR,ASSIST,FLIP DOWN FOR FCE1232 BED Back to Search Results
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.
 
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Brand NameMEDLINE
Type of DeviceBAR,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 Key10920025
MDR Text Key220629867
Report Number1417592-2020-00144
Device Sequence Number1
Product Code FNJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
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 Received11/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFCE1232ABN
Device Catalogue NumberFCE1232ABN
Device Lot Number54119110001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/16/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 11/30/2020 Patient Sequence Number: 1
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