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U.S. Department of Health and Human Services

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

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MEDLINE INDUSTRIES INC. MEDLINE MONITOR,BP,WRIST,DIGITAL UNIT Back to Search Results
Model Number MDS4003
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem Reaction to Medicinal Component of Device (4574)
Event Date 02/01/2021
Event Type  malfunction  
Manufacturer Narrative
End-user reports, the blood pressure monitor gave him the wrong reading and led him to believe that he needed to take more blood pressure medication. Resulting in end-user not feeling well and going to the hospital. Phone call placed to heui lee, end-user who stated, "he was not interested in speaking with me about this issue. " this clinician attempted/tried to leave a contact name and phone number however, end-user was not interested. No additional details are available related to the customer reported issue. Despite 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 incident 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
End-user reports, the blood pressure monitor gave him the wrong reading and led him to believe that he needed to take more blood pressure medication. Resulting in end-user not feeling well and going to the hospital.
 
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Brand NameMEDLINE
Type of DeviceMONITOR,BP,WRIST,DIGITAL UNIT
Manufacturer (Section D)
MEDLINE INDUSTRIES INC.
three lakes drive
northfield IL 60093
Manufacturer Contact
teresa maynard
three lakes drive
northfield, IL 60093
2249311514
MDR Report Key11396716
MDR Text Key256450347
Report Number1417592-2021-00026
Device Sequence Number1
Product Code DXN
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
Type of Report Initial,Followup
Report Date 03/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMDS4003
Device Catalogue NumberMDS4003
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/19/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/18/2021
Was Device Evaluated by Manufacturer? Yes
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: 03/01/2021 Patient Sequence Number: 1
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