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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUALITY PERFORMANCE LTD. KORE TRAK; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

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QUALITY PERFORMANCE LTD. KORE TRAK; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE Back to Search Results
Model Number KORE TRAK
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem Insufficient Information (4580)
Event Date 12/16/2020
Event Type  malfunction  
Event Description
Bought wrist type blood pressure measurement device that displays a false number and has no method to calibrate.Tried to discuss recall with seller, but they simply ignore claim.The device was found to display a blood pressure reading when hanging away from the wrist.Fda safety report id # (b)(4).
 
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Brand Name
KORE TRAK
Type of Device
SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
Manufacturer (Section D)
QUALITY PERFORMANCE LTD.
377 valley rd # 1123
clifton NJ 07013
MDR Report Key11377978
MDR Text Key233812861
Report NumberMW5099619
Device Sequence Number1
Product Code DXN
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date12/16/2021
Device Model NumberKORE TRAK
Device Catalogue NumberNONE
Device Lot NumberNONE
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/24/2021
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age74 YR
Patient Weight72
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