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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL CORPORATION C-QUR FX MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Migration (4003)
Patient Problems Abscess (1690); Cellulitis (1768); Hematoma (1884); Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Scarring (2061); Discomfort (2330)
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 pain, discomfort, scarring, infection, cellulitis, hematoma, abscess, nerve damage, loss of feeling, mesh migration, recurrence, and additional surgery. 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

Review of medical records, for this implant date, reveals that an additional mesh was not implanted.

 
Event Description

Review of medical records reveals this mesh was not implanted.

 
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Brand NameC-QUR FX
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 Key8423315
MDR Text Key138889267
Report Number3011175548-2019-00269
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK082748
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Type of Report Initial,Followup
Report Date 03/14/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/14/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/27/2019
Was Device Evaluated By Manufacturer? No
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: 03/14/2019 Patient Sequence Number: 1
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