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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL C-QUR V-PATCH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31200
Device Problem Microbial Contamination of Device (2303)
Patient Problems Emotional Changes (1831); Fatigue (1849); Unspecified Infection (1930); Pain (1994); Scarring (2061); Seroma (2069); Discomfort (2330); Deformity/ Disfigurement (2360)
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 severe abdominal pain increasing with activity, pain, discomfort, and tenderness in the area of the implant mesh infection, fluid collection/seroma, additional surgery to repair the hernia and remove infected mesh, 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.
 
Manufacturer Narrative
Investigation: 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 requirement.
 
Event Description
Plaintiff allegedly also experienced adhesions, recurrence, incarceration, fluid collection and brown drainage.
 
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Brand NameC-QUR V-PATCH
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 Key7402393
MDR Text Key104549165
Report Number3011175548-2018-00322
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K080688
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 04/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2017
Device Model Number31200
Device Catalogue Number31200
Device Lot Number205979
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/15/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/21/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/06/2018 Patient Sequence Number: 1
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