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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION PROLITE MESH MESH, SURGICAL, POLYMERIC

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ATRIUM MEDICAL CORPORATION PROLITE MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 1000306-00
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Cramp(s) (2193)
Event Date 12/11/2014
Event Type  Injury  
Manufacturer Narrative
A follow up report will be submitted upon the completion of the investigation into this event. Device not returned.
 
Event Description
Patient had repair of bilateral inguinal hernias and secondary repair of right inguinal hernia with mesh. An mri was performed to investigate back pain and difficulty walking. Patient reported multiple variable symptoms. Pain and cramping initiating from groin. Mesh was removed.
 
Manufacturer Narrative
As the lot number of the device that was implanted in 1999 was not provided a review of the device history records could not be conducted. Atrium medical corporation only releases product that has passed all quality and performance requirements. Based on the investigation atrium medical corporation cannot conclude that the symptoms the patient was experiencing was directly related to the prolite mesh. Clinical evaluation - the instructions for use (ifu) states adequate mesh fixation is required to minimize post-operative complications and recurrence. The fixation technique, method and products used (including sutures, tacks, staples or other means) is left to the discretion of the surgeon to optimize clinical outcomes. The ifu also states complications that may occur with the use of any surgical mesh include, but are not limited to pain, inflammation, infection, allergic reaction, seroma, hematoma, fistula formation or mechanical disruption of the tissue and/or mesh material and possibly adhesions when placed in direct contact with the viscera and other organs.
 
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Brand NamePROLITE MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
40 continental blvd
merrimack NH 03054
Manufacturer (Section G)
ATRIUM MEDICAL CORPORATION
40 continental blvd
merrimack NH 03054
Manufacturer Contact
40 continental blvd
merrimack, NH 03054
MDR Report Key9764966
MDR Text Key181210516
Report Number3011175548-2020-00329
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K930669
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 02/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1000306-00
Device Catalogue Number1000306-00
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/23/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/27/2020 Patient Sequence Number: 1
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