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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C-QUR MESH; MESH, SURGICAL, POLYMERIC
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C-QUR MESH; MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Pain (1994); Skin Inflammation/ Irritation (4545)
Event Type  Injury  
Manufacturer Narrative
We are unable to fully investigate this event as no product code, lot number, or sample was provided.
 
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 and suffering, hernia repair, displaced mesh and inflammation.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 incarceration.
 
Manufacturer Narrative
Additional information section: a2, b5, b7, h6.
 
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Brand Name
C-QUR MESH
Type of Device
MESH, SURGICAL, POLYMERIC
MDR Report Key12064307
MDR Text Key258316423
Report Number3011175548-2021-00708
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 11/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received10/14/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age54 YR
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