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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOGUARD; SYSTEM, COLORECTAL NEOPLASIA, AND HEMOGLOBIN DNA METHYLATION DETECTION
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COLOGUARD; SYSTEM, COLORECTAL NEOPLASIA, AND HEMOGLOBIN DNA METHYLATION DETECTION Back to Search Results
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Death (1802); Pain (1994); Cancer (3262)
Event Date 08/01/2017
Event Type  Death  
Event Description
My sister, (b)(6) saw commercials for cologuard on tv and decided it would be much easier than getting a colonoscopy.She talked to her physician, who ordered cologuard for her.Her results were negative for colon cancer.However, after having severe back pain about a year later, she went to the emergency room at the (b)(6) medical center in (b)(6), the end of (b)(6) 2018.An mri or scan showed she had multiple tumors on her colon.Her diagnosis was colon cancer with no treatment available that would put her in remission.She died 12 days later on (b)(6) 2018.I believe cologuard's commercial on tv are very misleading and deceptive stating if you're at average risk for colon cancer why take 2 days off work or drink that horrible liquid for prep, just ask your dr to order cologuard.You can call me, (b)(6), on (b)(6) if you need add'l info.
 
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Brand Name
COLOGUARD
Type of Device
SYSTEM, COLORECTAL NEOPLASIA, AND HEMOGLOBIN DNA METHYLATION DETECTION
MDR Report Key8277562
MDR Text Key134189605
Report NumberMW5083352
Device Sequence Number1
Product Code PHP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 01/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death; Hospitalization;
Patient Age67 YR
Patient Weight61
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