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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 30902
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Hernia (2240)
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. Not returned.
 
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 recurrent hernia and revision surgery on (b)(6) 2016 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 Key14555954
MDR Text Key293056519
Report Number3011175548-2022-00152
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K930669
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 05/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2016
Device Model Number30902
Device Catalogue Number30902
Device Lot Number10786309
Was Device Available for Evaluation? No
Date Manufacturer Received05/20/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/01/2011
Is the Device Single Use? Yes
Type of Device Usage

Patient Treatment Data
Date Received: 05/31/2022 Patient Sequence Number: 1
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