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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL C-QUR TACSHIELD MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31633
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Fistula (1862); Failure of Implant (1924); Unspecified Infection (1930); Pain (1994); Seroma (2069); Discomfort (2330); Fibrosis (3167)
Event Type  Injury  
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 requirement. This report is based upon allegations made in a lawsuit in which atrium medical would be named as a defendant. This report shall not be considered as an admission by atrium medical that the product described in the pre-suit claim and described herein is or was defective, or that it had any causal relationship to any injuries allegedly suffered by the claimant.
 
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 severe abdominal pain increasing with activity, pain, discomfort, and tenderness, bowel adhesions, mesh infection, fluid collection/seroma, surgery to repair the hernia, remove infected mesh, mesh protrusion, fibrosis, fistula, mental anguish, severe emotional distress, permanent and severe scarring and disfigurement. 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 granulation tissue, foreign body giant cell reaction and inflammation.
 
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Brand NameC-QUR TACSHIELD
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL
40 continental blvd
merrimack NH 03054
Manufacturer (Section G)
ATRIUM MEDICAL
40 continental blvd
merrimack NH 03054
Manufacturer Contact
40 continental blvd
merrimack, NH 03054
MDR Report Key7408772
MDR Text Key104755760
Report Number3011175548-2018-00335
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 04/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2013
Device Model Number31633
Device Catalogue Number31633
Device Lot Number106994230
Other Device ID Number00650862316339
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/19/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/27/2010
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: 04/09/2018 Patient Sequence Number: 1
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