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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 Problem Appropriate Term/Code Not Available (3191)
Patient Problems Adhesion(s) (1695); Pain (1994); Hernia (2240)
Event Type  Injury  
Manufacturer Narrative
We are unable to fully investigate this event as no product code, lot number, or sample was provided.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 pain, revision, recurrence, scarring, and adhesions.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
Plaintiff also allegedly experienced mesh contraction.
 
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.
 
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Brand Name
C-QUR MESH
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
40 continental blvd
merrimack NH 03054
MDR Report Key9537054
MDR Text Key173274622
Report Number3011175548-2019-01274
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 12/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date04/26/2020
Device Model Number31528
Device Catalogue Number31528
Device Lot Number414827
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/27/2019
Initial Date FDA Received12/31/2019
Supplement Dates Manufacturer Received03/23/2020
Supplement Dates FDA Received04/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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