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U.S. Department of Health and Human Services

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

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MEDLINE INDUSTRIES INC. MEDLINE RAIL,SIDE,HEAD SECTION,SOFT TOUCH Back to Search Results
Model Number FCE1232RSRN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Laceration(s) (1946)
Event Date 05/31/2021
Event Type  Injury  
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 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.
 
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Brand NameMEDLINE
Type of DeviceRAIL,SIDE,HEAD SECTION,SOFT TOUCH
Manufacturer (Section D)
MEDLINE INDUSTRIES INC.
three lakes drive
northfield IL 60093 2753
Manufacturer Contact
karen trutsch
three lakes drive
northfield, IL 60093-2753
MDR Report Key12104062
MDR Text Key259584966
Report Number1417592-2021-00113
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 health professional
Reporter Occupation
Type of Report Initial
Report Date 07/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberFCE1232RSRN
Device Catalogue NumberFCE1232RSRN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 07/01/2021 Patient Sequence Number: 1
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