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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK VERITAS COLLAGEN MATRIX OR SURGISIS COLD HERNIA REPAIR GRAFT

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COOK VERITAS COLLAGEN MATRIX OR SURGISIS COLD HERNIA REPAIR GRAFT Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Autoimmune Reaction (1733); Fatigue (1849); Rash (2033)
Event Type  Injury  
Event Description
This biologic mesh was put in on (b)(6) 2008 by dr. (b)(6). During open gastric bypass to prevent a hernia. Symptoms were worsening, starting with a rash of over-lying skin at implant area, autoimmune type symptoms similar to sjogrens but i did not have the antibodies to sjogrens, lupus or any other autoimmune disease. The cause was unknown - a mystery illness. I can still no longer cry or make tears. At the time, i had no saliva, tears, had 4 plus needles chronic fatigue and i developed r. Mass 11 months later as the mesh was going through resorption. The mesh was removed on (b)(6) 2009 by dr. (b)(6). Dr. (b)(6) remarked to me that he found the mesh (or portion of it) inside of the mass that was removed during surgery. This was not written in the surgical report. In fact, neither doctor (the one who put the mesh in or the one who removed the mass) ever reported my symptoms, despite my telling them, so i am reporting it myself now. Called sales rep. (b)(4) to ask what device was made of and asked concerning questions on: (b)(6) 2009. Implant has resorption. This was a biologic mesh made from the small intestine of a pig. Ask cook at (b)(4). Devices were supplied to dr. (b)(6) for hernia protection during open gastric bypass surgery.
 
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Brand NameVERITAS COLLAGEN MATRIX OR SURGISIS COLD HERNIA REPAIR GRAFT
Type of DeviceVERITAS COLLAGEN MATRIX OR SURGISIS COLD HERNIA REPAIR GRAFT
Manufacturer (Section D)
COOK
MDR Report Key6540569
MDR Text Key74411577
Report NumberMW5069512
Device Sequence Number1
Product Code FTM
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 05/02/2017 Patient Sequence Number: 1
Treatment
OTC MEDS: WOMAN'S ONE A DAY MULTIVITAMINS.; PYRIDIUM; RX MEDS: VIVELLE.DOT ESTRADIOL PATCH
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