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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL CORPORATION MESH PROLOOP PLUGS MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 30901
Device Problems Structural Problem (2506); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Pain (1994)
Event Type  Injury  
Manufacturer Narrative
Investigation: based on the review of the device history records and product complaint details atrium can find no fault with the product. This lot of mesh passed all quality and performance requirement. This report is based upon allegations made in a potential lawsuit in which atrium medical would be named as a defendant.
 
Event Description
This event is deemed reportable based on the allegations in a potential lawsuit which, while unsubstantiated, suggest that a reportable event may have occurred during use of an atrium medical mesh product. Plaintiff allegedly experienced chronic pain, balled mesh, and additional surgery as a result of the implantation of the mesh implant. Since this is a potential 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 NameMESH PROLOOP PLUGS
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
40 continental blvd
merrimack NH
Manufacturer (Section G)
ATRIUM MEDICAL CORPORATION
40 continental blvd
merrimack NH
Manufacturer Contact
lori gosselin
40 continental blvd
merrimack, NH 
MDR Report Key12485754
MDR Text Key271853381
Report Number3011175548-2021-00957
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K930669
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial
Report Date 09/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2020
Device Model Number30901
Device Catalogue Number30901
Device Lot Number400479
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/01/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/17/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 09/16/2021 Patient Sequence Number: 1
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