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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION VITA MESH PROLENE POLYPROPYLENE; MESH, SURGICAL, POLYMERIC
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ATRIUM MEDICAL CORPORATION VITA MESH PROLENE POLYPROPYLENE; MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problems Patient-Device Incompatibility (2682); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Failure of Implant (1924); Pain (1994); Hernia (2240); No Code Available (3191)
Event Date 10/20/2015
Event Type  Injury  
Event Description
Bowel obstruction, adhesions; i had an atrium vita mesh prolene, polypropylene, my body is rejecting the material in the mesh, had hernia repair surgery (b)(6) 2016, my health has gone down hill, hospitalized every month with bowel obstruction, adhesions, lesions, the area where the abdominal mesh was put in, having kidney issues, pancreatitis, gerd , barrett's esophagus, chronic pain, and another hernia, i have been sent to the mayo clinic, can't afford to go, my mesh is intertwined with the tissue in my stomach, feels like i have the flu 24/7, my quality of life has been destroyed.Disabled due to my body rejecting the prolene polypropylene material.Hernia repair surgery, 2016, still being treated for the issues that my body is rejecting the material.Again i have been hospitalized since (b)(6) "2027" every month.The surgeon did tell me that if they do any surgery i would bleed to death, due to the mesh being intertwined with my stomach tissue.The mesh caused my "parstasle" muscles to become paralyzed c.Fda safety report id# (b)(4).
 
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Brand Name
VITA MESH PROLENE POLYPROPYLENE
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
MDR Report Key10086812
MDR Text Key192184558
Report NumberMW5094664
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Disability;
Patient Age50 YR
Patient Weight54
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