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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION OTHER MESH MESH, SURGICAL, POLYMERIC

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ATRIUM MEDICAL CORPORATION OTHER MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Material Separation (1562)
Patient Problems Adhesion(s) (1695); Pain (1994); Hernia (2240)
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 an atrium medical mesh product. Plaintiff allegedly experienced hernia recurrence, pain and suffering, emotion distress component separation and adhesions, as a result of the implantation of the mesh implant. 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 NameOTHER MESH
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 Key10650796
MDR Text Key210480427
Report Number3011175548-2020-01194
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Type of Report Initial
Report Date 10/08/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/08/2020
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 Received09/14/2020
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: 10/08/2020 Patient Sequence Number: 1
Treatment
ALBUTEROL, QVAR INHALER, ZOLOFT, ZANTAC, NORCO
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