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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 30900
Health Effect - Clinical Code Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event Serious Injury
Additional 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 or Problem 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 unspecified injuries and complications 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 Name
MESH PROLOOP PLUGS
Common Device Name
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
40 continental blvd
merrimack NH
MDR Report Key11590941
Report Number3011175548-2021-00383
Device Sequence Number3499162
Product Code FTL
UDI-Device Identifier00650862309003
UDI-Public00650862309003
Combination Product (Y/N)N
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 03/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date11/03/2022
Device Model Number30900
Device Catalogue Number30900
Device Lot Number423144
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/22/2021
Initial Report FDA Received Date03/30/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age21 YR
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