• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION C-QUR MESH MESH, SURGICAL, POLYMERIC

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ATRIUM MEDICAL CORPORATION C-QUR MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31528
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Adhesion(s) (1695); Fistula (1862); Unspecified Infection (1930); Seroma (2069)
Event Type  Injury  
Manufacturer Narrative

We are unable to fully investigate this event as no product code, lot number, or sample was provided. This report is based upon allegations made in a lawsuit in which atrium medical is named as a defendant. This report shall not be considered as an admission by atrium medical that the product described in the lawsuit claim and described herein is or was defective, or that it had any causal relationship to any injuries allegedly suffered by the plaintiff.

 
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 infection and perforation. 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.

 
Manufacturer Narrative

Based on the review of the device history and sterilization records and product complaint details atrium can find no fault with the product. This lot of mesh passed all quality and performance requirements.

 
Event Description

Plaintiff also allegedly experienced recurrence, induration, hole in the small bowel, pain adhesions, abscess, drainage, small bowel resection, fistula, balled up mesh, seroma, and abdominal binder placement.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameC-QUR MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
40 continental blvd
merrimack NH
Manufacturer (Section G)
ATRIUM MEDICAL CORPORATION
40 continental blvd
merrimack NH
Manufacturer Contact
40 continental blvd
merrimack, NH 
MDR Report Key11713238
MDR Text Key249648668
Report Number3011175548-2021-00435
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK050311
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Type of Report Initial,Followup
Report Date 04/22/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/23/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2017
Device MODEL Number31528
Device Catalogue Number31528
Device LOT Number202492
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/12/2021
Was Device Evaluated By Manufacturer? No
Date Device Manufactured04/08/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 04/23/2021 Patient Sequence Number: 1
-
-