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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
Model Number 31636
Device Problems Contamination (1120); Migration or Expulsion of Device (1395)
Patient Problems Abdominal Pain (1685); Abdominal Pain (1685); Abscess (1690); Abscess (1690); Adhesion(s) (1695); Adhesion(s) (1695); Erosion (1750); Erosion (1750); Emotional Changes (1831); Emotional Changes (1831); Fistula (1862); Fistula (1862); Foreign Body Reaction (1868); Foreign Body Reaction (1868); Inflammation (1932); Inflammation (1932); Nerve Damage (1979); Nerve Damage (1979); Scarring (2061); Seroma (2069); Seroma (2069); Tissue Damage (2104); Tissue Damage (2104); Hernia (2240); Hernia (2240); Impaired Healing (2378); Impaired Healing (2378); Reaction (2414); Reaction (2414); Obstruction/Occlusion (2422); Post Operative Wound Infection (2446); Post Operative Wound Infection (2446); Blood Loss (2597)
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 removal of infected mesh, removal of adhesions, bowel obstruction, abdominal pain, wound infection, improper healing inadequate or failure of incorporation/ingrowth, chronic pain, recurrence of hernia, foreign body response, rejection, mesh migration, excessive and chronic inflammation, scarification, granulomatous response, allergic reaction, adhesions to internal organs, erosion, abscess, fistula formation, seroma formation, nerve damage, tissue damage and emotional distress. 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 device history and sterilization records and product complaint details atrium can find no fault with the product. This lot of mesh passed all quality and performance requirements.
 
Event Description
Plaintiff also allegedly experienced unincorporated mesh and blood loss.
 
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Brand NameC-QUR TACSHIELD
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
40 continental blvd
merrimack NH 03054
Manufacturer (Section G)
ATRIUM MEDICAL CORPORATION
40 continental blvd
merrimack NH 03054
Manufacturer Contact
40 continental blvd
merrimack, NH 03054
MDR Report Key8409340
MDR Text Key138435923
Report Number3011175548-2019-00242
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 03/11/2019
2 Devices were Involved in the Event: 1   2  
2 Patients were Involved in the Event: 1   2  
Date FDA Received03/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2017
Device Model Number31636
Device Catalogue Number31636
Device Lot Number214199
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/02/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/18/2014
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: 03/11/2019 Patient Sequence Number: 0
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