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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MONITOR,BP,WRIST,DIGITAL UNIT

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MEDLINE INDUSTRIES INC. MONITOR,BP,WRIST,DIGITAL UNIT Back to Search Results
Catalog Number MDS4003
Device Problem Low Readings (2460)
Patient Problem Low Blood Pressure/ Hypotension (1914)
Event Date 08/13/2020
Event Type  Injury  
Manufacturer Narrative
It was reported by end user that medline product mds4003, digital wrist blood pressure monitor unit with wrist cuff "was giving really low readings and the end user had to go to the emergency room for medication. " despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer. Due to the reported nature of the incident and medical intervention reported this medwatch is being filed. The sample was not returned therefore a root cause has not been determined at this time. No further information is available. If additional relevant information becomes available, this report will be reopened and reevaluated.
 
Event Description
It was reported the blood pressure monitor was giving "really low readings and the end user had to go to the emergency room for medication. ".
 
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Type of DeviceMONITOR,BP,WRIST,DIGITAL UNIT
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 Key10511735
MDR Text Key206290075
Report Number1417592-2020-00095
Device Sequence Number1
Product Code DXN
UDI-Device Identifier00888277675493
UDI-Public00888277675493
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 09/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberMDS4003
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/14/2020
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: 09/09/2020 Patient Sequence Number: 1
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