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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL PROLITE MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 1000306-00
Device Problem Insufficient Information (3190)
Patient Problems Adhesion(s) (1695); Scarring (2061); Hernia (2240)
Event Type  Injury  
Manufacturer Narrative
Investigation: based on the review of the device history records and product complaint details atrium can find no fault with the product. This lot of mesh passed all quality and performance requirement.
 
Event Description
This event is deemed reportable based on the allegations in a lawsuit which, while unsubstantiated, suggest that a reportable event may have occurred during use of atrium medical¿s mesh product. Plaintiff allegedly experienced port site hernia, epigastric hernia, umbilical hernia, incisional hernia, recurrence, scarring, adhesion and unincorporated mesh. Since this is a legal matter, the case has been turned over to legal counsel and further information obtained through investigation or discovery may fall under the attorney/client and/or work product privilege. However, atrium will supplement this report as appropriate if additional information comes to its attention.
 
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Brand NamePROLITE MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL
40 continental blvd
merrimack NH 03054
Manufacturer (Section G)
ATRIUM MEDICAL
40 continental blvd
merrimack NH 03054
Manufacturer Contact
40 continental blvd
merrimack, NH 03054
MDR Report Key8205275
MDR Text Key131698175
Report Number3011175548-2018-01549
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial
Report Date 12/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2018
Device Model Number1000306-00
Device Catalogue Number1000306-00
Device Lot Number10877271
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received12/13/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/11/2013
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: 12/29/2018 Patient Sequence Number: 1
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