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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION C-QUR TACSHIELD; MESH, SURGICAL, POLYMERIC
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ATRIUM MEDICAL CORPORATION C-QUR TACSHIELD; MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Material Fragmentation (1261)
Patient Problems Pain (1994); Seroma (2069); 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 multiple additional surgeries, mesh debris left powdery gold appearance, drainage, seroma, adhesions, chronic pain multiple strangulated recurrent hernias.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 medical records this mesh was not an implanted device.
 
Event Description
Based on the review of the medical records this mesh was not an implanted device.
 
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Brand Name
C-QUR TACSHIELD
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
40 continental blvd
merrimack NH
MDR Report Key11190273
MDR Text Key227485900
Report Number3011175548-2021-00047
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K100076
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 01/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2021
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 Received03/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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