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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL CORPORATION C-QUR MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31528
Device Problems Patient-Device Incompatibility (2682); Migration (4003)
Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Erosion (1750); Emotional Changes (1831); Fistula (1862); Foreign Body Reaction (1868); Granuloma (1876); Hypersensitivity/Allergic reaction (1907); 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 not able to thoroughly investigate this report as not lot number 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 surgical revision, 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.

 
Event Description

N/a.

 
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.

 
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Brand NameC-QUR MESH
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 Key8119974
MDR Text Key128917193
Report Number3011175548-2018-01421
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
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/30/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/30/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/31/2012
Device MODEL Number31528
Device Catalogue Number31528
Device LOT Number10564962
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? 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 Manufactured12/21/2009
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: 11/30/2018 Patient Sequence Number: 1
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