• 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 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 C-QUR MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31540
Device Problem Migration (4003)
Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Erosion (1750); Emotional Changes (1831); Fistula (1862); Foreign Body Reaction (1868); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Nerve Damage (1979); Scarring (2061); Seroma (2069); Tissue Damage (2104); Hernia (2240); Impaired Healing (2378); Obstruction/Occlusion (2422); Post Operative Wound Infection (2446)
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.
 
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 surgical revision including removal of infected mesh, removal of adhesions, bowel obstruction, abdominal pain, wound infection, improper healing inadequate or failure of incorporation/ingrowth, chronic pain, recurrence of hernia, foreign body response, rejection, mesh migration, excessive and chronic inflammation, scarification, granulomatous response, allergic reaction, adhesions to internal organs, erosion, abscess, fistula formation, seroma formation, nerve damage, tissue damage and/or other complications and emotional distress. 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameC-QUR MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL
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 Key7682920
MDR Text Key113817623
Report Number3011175548-2018-00703
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K050311
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 07/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2015
Device Model Number31540
Device Catalogue Number31540
Device Lot Number10856978
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received04/05/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/09/2012
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: 07/12/2018 Patient Sequence Number: 1
-
-