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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL ABDOMINAL MESH

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ATRIUM MEDICAL ABDOMINAL MESH Back to Search Results
Device Problem Defective Device (2588)
Patient Problems Bruise/Contusion (1754); Hemorrhage/Bleeding (1888); Ambulation Difficulties (2544); No Code Available (3191)
Event Date 05/01/2015
Event Type  Injury  
Event Description
I want to know why atrium medical company is still selling mesh products. They were closed down, opened up under 2 different names. I had an abdominal mesh put in by atrium company, the drs and hospitals were getting with this scam now won't help me. I am permanently disabled, lost everything i owned, the most important is my health. I am too sick to walk, sit and work. I loved my job working as a hospital technician, 10 years in the field. I am so upset. Thank god for the whistle blowers at atrium medical company, the truth now will be exposed to everyone. How can anyone allow this to happen, the doctors know they messed up now won't help me - thank god i am finally working with drs that care. This isn't over. I had a good solid job, goals for myself, this isn't over. Have all the information that no one bothered to tell the public about. I begged for a mesh not to be put in. The doctor didn't listen. Type of injury: bleeding, bruising, scratches, deformed stomach. Defective mesh.
 
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Brand NameABDOMINAL MESH
Type of DeviceABDOMINAL MESH
Manufacturer (Section D)
ATRIUM MEDICAL
MDR Report Key6793912
MDR Text Key82858425
Report NumberMW5071556
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
Type of Report Initial
Report Date 08/14/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/11/2017
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

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