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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL PROLITE ULTRA MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 30717
Device Problem Material Separation (1562)
Patient Problems Adhesion(s) (1695); Blood Loss (2597)
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 recurrence, adhesions, component separation, blood loss, serosal tears and enteromy. 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 ULTRA 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 Key8327738
MDR Text Key135846932
Report Number3011175548-2019-00167
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K002093
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2016
Device Model Number30717
Device Catalogue Number30717
Device Lot Number10799574
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received01/30/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/11/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/11/2019 Patient Sequence Number: 1
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