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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL CORPORATION C-QUR V-PATCH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31202
Device Problems Patient-Device Incompatibility (2682); Migration (4003)
Patient Problems Foreign Body Reaction (1868); Unspecified Infection (1930); Pain (1994)
Event Type  Injury  
Manufacturer Narrative

We are unable to fully investigate this event as no product code, lot number, or sample was provided. Device evaluated by manufacturer? 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 surgical revision, adhesions, bowel obstruction, 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, erosion, abscess, fistula, seroma, 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.

 
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Brand NameC-QUR V-PATCH
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 Key10244557
MDR Text Key197929819
Report Number3011175548-2020-00882
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK090909
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Type of Report Initial,Followup
Report Date 07/08/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/08/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/31/2015
Device MODEL Number31202
Device Catalogue Number31202
Device LOT Number10866251
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured01/04/2013
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: 07/08/2020 Patient Sequence Number: 1
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