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U.S. Department of Health and Human Services

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

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MEDLINE INDUSTRIES INC. BAR,ASSIST,FLIP DOWN FOR FCE1232 BED Back to Search Results
Catalog Number FCE1232ABN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Laceration(s) (1946)
Event Date 07/31/2020
Event Type  Injury  
Manufacturer Narrative
It was reported that a patient on fall precautions experienced a backward fall while trying to get out of bed. According to the facility contact, the assist bar did not cause or contribute to the fall that was experienced. The facility contact states that a plastic piece on the assist bar had previously fallen off. When the patient fell, she hit the base of the back of her head on the metal part of the assist bar and experienced a head laceration. The patient was taken to a local hospital. A ct scan was performed with no acute findings reported. The patient reportedly received five (5) internal sutures and three (3) external sutures to close the head laceration. The patient was discharged after evaluation and treatment and is reportedly "recovering and doing okay at this time. " no sample was returned to the manufacturer for evaluation. A root cause for the reported incident was unable to be determined. Due to the reported need for medical intervention, this medwatch is being filed. If additional relevant information becomes available a supplemental medwatch will be filed.
 
Event Description
It was reported that a patient experienced a backward fall and hit her head on the assist bar.
 
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Type of DeviceBAR,ASSIST,FLIP DOWN FOR FCE1232 BED
Manufacturer (Section D)
MEDLINE INDUSTRIES INC.
three lakes drive
northfield, il
Manufacturer Contact
nigel vilches
three lakes drive
northfield, il 
9311458
MDR Report Key10456106
MDR Text Key204529945
Report Number1417592-2020-00057
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 user facility
Reporter Occupation
Type of Report Initial
Report Date 08/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberFCE1232ABN
Device Lot Number54119110001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/06/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/26/2020 Patient Sequence Number: 1
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