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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL CORPORATION MESH PROLITE SHEETS MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 1000104-00
Device Problems Material Separation (1562); Material Deformation (2976)
Patient Problems Adhesion(s) (1695); Pain (1994)
Event Type  Injury  
Manufacturer Narrative

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 requirements. Not returned.

 
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 shrunken mesh, dense adhesions, lysis of adhesions, pain, recurrence, and component separation. 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 NameMESH PROLITE SHEETS
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 Key10084758
MDR Text Key191962980
Report Number3011175548-2020-00705
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK930669
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Type of Report Initial
Report Date 05/24/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/24/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/31/2018
Device MODEL Number1000104-00
Device Catalogue Number1001014-00
Device LOT Number10910246
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/28/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured10/18/2013
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: 05/24/2020 Patient Sequence Number: 1
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