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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL C-QUR MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31533
Device Problems Material Twisted/Bent (2981); Appropriate Term/Code Not Available (3191)
Patient Problems Adhesion(s) (1695); Pain (1994); Patient Problem/Medical Problem (2688)
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 recurrent incisional hernia requiring placement of new mesh for repair, lysis of adhesions, shrinking and rolling of c-qur mesh, bowel of jejunum adherent to mesh and pain. 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 allegedly also experienced incarceration.
 
Manufacturer Narrative
Investigation: 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 requirement.
 
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Brand NameC-QUR MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL
40 continental blvd
merrimack NH 03054
MDR Report Key7822729
MDR Text Key118437332
Report Number3011175548-2018-00931
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 08/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2013
Device Model Number31533
Device Catalogue Number31533
Device Lot Number10622731
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/18/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/28/2018 Patient Sequence Number: 1
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