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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC. SURELIFE; BLOOD PRESSURE MONITOR
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MHC MEDICAL PRODUCTS, LLC. SURELIFE; BLOOD PRESSURE MONITOR Back to Search Results
Catalog Number 860213
Device Problem Incorrect Measurement (1383)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/29/2018
Event Type  malfunction  
Event Description
Blood pressure monitor; started reading high about 3 months ago.While at her doctor appointment, she compared results with the doctor's machine.Dr's result 109, sl result- 143.She asked her dr.To look at it for her, but they told her to call the 800 number and have a replacement sent.She also requested a bigger cuff to be sent due to the standard cuff not fitting properly.A return label will be requested.
 
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Brand Name
SURELIFE
Type of Device
BLOOD PRESSURE MONITOR
Manufacturer (Section D)
MHC MEDICAL PRODUCTS, LLC.
11930 kemper springs drive
cincinnati OH 45240
Manufacturer (Section G)
MHC MEDICAL PRODUCTS, LLC.
11930 kemper springs drive
cincinnati OH 45240
Manufacturer Contact
jennifer seiple
11930 kemper springs drive
cincinnati, OH 45240
MDR Report Key7728840
MDR Text Key115353405
Report Number3005798905-2018-00739
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091434
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Non-Healthcare Professional
Remedial Action Replace
Type of Report Initial
Report Date 07/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number860213
Was Device Available for Evaluation? No
Date Manufacturer Received06/29/2018
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 Reuse
Patient Sequence Number1
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