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

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.

• Brand Name: VERITAS COLLAGEN MATRIX OR SURGISIS COLD HERNIA REPAIR GRAFT
• Type of Device: VERITAS COLLAGEN MATRIX OR SURGISIS COLD HERNIA REPAIR GRAFT
• Manufacturer (Section D): COOK
• MDR Report Key: 6540569
• MDR Text Key: 74411577
• Report Number: MW5069512
• Device Sequence Number: 1
• Product Code: FTM
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 05/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OTC MEDS: WOMAN'S ONE A DAY MULTIVITAMINS.; PYRIDIUM; RX MEDS: VIVELLE.DOT ESTRADIOL PATCH
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 59